package insert contains a warning of the inaccuracy of the machine for patients with Antiphospholipid Antibody Syndrome

see attached file page 2 !!!!!!!!!!!!!!!!!!!!!!!!

Tests

This is a CLIA waived system. These test strips are to be used with the

CoaguChek System.

Intended Use

For quantitative prothrombin time (PT) testing in fresh capillary or venous

whole blood with the CoaguChek System by professional healthcare

providers.

Cat. No. 3116247

48 Test Strips

1 Code Chip

Introduction

Blood coagulation is one of the body’s protective responses. Blood clots

(thrombi) form as a direct response to vessel injury, preventing excessive

loss of blood. Certain disease conditions require oral anticoagulants,

sometimes known as blood thinners. Warfarin, which is sometimes

known as Coumadin®, is a commonly used anticoagulant. Patients on

warfarin must be carefully monitored to ensure the anticoagulant level is

maintained in the therapeutic range. One method for monitoring the

anticoagulant level is by using the one-stage Prothrombin Time (PT) Test.

The CoaguChek Systems Test uses a modified version of this method.

Test Principle

The CoaguChek Systems Test, used as directed with the CoaguChek

Monitor, will accurately measure blood PT values. After placing a drop of

fresh whole blood on the test strip, the blood is drawn into the reaction

chamber and mixed with reagents that cause coagulation to begin. In the

test strip, tiny iron particles are mixed with the sample. Alternating

magnetic fields cause the iron particles to move within the sample.1 The

endpoint is reached when the blood clot stops the iron particles from

moving. The PT result is then displayed by the monitor.2

Read the CoaguChek System User’s Manual for complete instructions.

If you have questions, call Point of Care Technical Service Center at

1-800-428-4674, 24 hours a day, 7 days a week.

Reagents

Each test strip contains rabbit thromboplastin, stabilizers, and

preservatives.

Precautions and Warnings:

1. For in vitro diagnostic use. Do not take internally.

2. Exercise the normal precautions required for handling all blood

specimens and laboratory reagents. Follow your facility’s infection

control guidelines.

3. CoaguChek Systems Tests may be performed with fresh capillary

whole blood from a fingerstick or fresh venous whole blood drawn in

an anticoagulant-free plastic syringe.

4. Never add more blood to the test strip after the test has begun, or

perform another test using the same fingerstick.

Storage and Stability:

• Keep strips in the original sealed foil pouches.

• Store strips in refrigerator at +2°C to +8°C (+36°F to +46°F) until

ready to use. Do not freeze. Test strips are stable for 60 days or until

the expiration date, whichever comes first, when stored at room

temperature (below 32°C or 90°F).

• Remove only the necessary number of foil pouches from the

refrigerator needed to perform a test(s). Test strips must be out of the

refrigerator for at least five minutes before use.

• Once the foil pouch has been opened, use the strip within four

minutes.

Before Testing

Gather the necessary materials:

• CoaguChek Monitor

• CoaguChek Systems Tests

• Test Strip Code Chip

• Alcohol wipe

• Cotton ball

For capillary specimen collection, you will need:

• Lancets

• Lancet device

• CoaguChek Capillary Blood Collection System, Cat. No. 461 (optional)

For venous specimen collection, you will need:

• Plastic syringe free of anticoagulants.

• Syringe needle should be 23 gauge or larger. A 21 gauge or larger

needle is recommended.

• Tourniquet

1. If you are using test strips from a new unopened box, you will need

to change the Test Strip Code Chip. The first three numbers after

the lot symbol on the test strip pouch should match the numbers on

the Test Strip Code Chip. To install the Test Strip Code Chip:

• Turn the monitor off.

• Remove and discard the old Code Chip, if one is installed.

• Insert the new Test Strip Code Chip until it snaps into place. Make

sure the label side with code number is up.

• Refer to the CoaguChek User’s Manual for additional information.

2. Remove foil pouch from refrigerator. Test strips must be out of the

refrigerator for at least five minutes before use.

3. For capillary sample collection:

Prepare lancet device according to manufacturer’s instructions.

• Set aside until needed.

Prepare capillary collection device (optional).

• Firmly insert end of capillary tube into the capillary bulb. With

each new bulb, be sure to completely insert the capillary tube

into the bulb.

• Set aside until needed.

4. For venous sample collection:

• Prepare a plastic syringe that is free of anticoagulants. The

sample must be used immediately after collection.

• Plasma or serum cannot be used as a testing sample.

• Glass tubes or syringes must not be used.

Testing

The CoaguChek Systems Test uses only fresh capillary or venous, nonanticoagulated

whole blood. Depending on the sample collection method,

use method A or B as they apply below.

1. Place monitor on a flat, horizontal surface, free of vibrations, before

testing.

2. Turn the monitor on. When PERFORM TEST? appears on the display,

press the YES button and the instruction INSERT STRIP will appear.

3. Open foil pouch at the tear mark on the side of the pouch and remove

test strip.

4. Insert strip into monitor, printed side up. Make sure you insert the test

strip in the direction of the printed arrows. You will see the yellow

sample target area through the strip. The monitor displays IS THIS A

CONTROL? Press the NO button. The monitor then displays PLEASE

WAIT. The monitor will warm the strip for about 45 seconds.

5. When monitor displays APPLY SAMPLE prepare to collect the fresh

whole blood sample.

Method A - Capillary sample collection

• Clean finger with alcohol wipe or use soap and warm water. Dry

finger thoroughly.

• Stick the fingertip by placing the tip of lancet device against the

bottom side of the finger and pushing the trigger button. Gently

squeeze finger until a hanging drop of blood forms.

• Touch the capillary tube to the blood drop. Fill the capillary tube

halfway. Avoid getting air bubbles into the sample. Do not touch the

bulb during sample collection. If blood gets into the capillary bulb

during sample collection, discard the bulb.

• Put finger over hole at the top of the capillary bulb. When the

monitor displays APPLY SAMPLE, hold the capillary tube directly over

the sample target area of the test strip. While keeping finger over

the hole, gently push down the top of the bulb until the sample has

been expelled onto the sample target of the test strip. Make sure the

test strip is flat when testing. Make sure the sample touches the

channel surrounding the yellow target zone. The entire target area of

the test strip must be completely filled.

• Apply sample to test strip within 15 seconds of lancing the fingertip.

Note: Blood may also be applied directly from the finger to the

sample target area. The entire target area must be filled completely

with one hanging drop of blood.

Method B - Venous sample collection

• When the monitor displays APPLY SAMPLE, draw the venous sample

into a plastic syringe free of anticoagulants.

• Discard the first four drops of blood from the needle, then

immediately place one drop of blood from syringe needle directly

onto the center of the sample target of the test strip. Make sure the

test strip is flat when testing. Make sure the sample touches the

channel surrounding the yellow target zone. The entire target area of

the test strip must be completely filled.

6. When the blood enters the testing area of the strip, the monitor will

display TESTING along with a progress bar. Do not add more blood or

touch the test strip while TESTING is displayed. The strip should not be

disturbed until the monitor displays the PT value.

7. Remove the test strip.

8. The monitor stores the PT value in memory, along with the date and

time the test was performed. You may also record the PT value in a log

book.

9. Carefully discard lancet and capillary tube or needle and syringe and

the used test strip according to proper infection control guidelines.

Expected Results

CoaguChek System test results are displayed in units equivalent to

laboratory plasma measurements. Results may be displayed in the

International Normalized Ratio (INR=(PT/Median Normal PT)ISI), seconds,

% Quick (a unit used mainly by healthcare professionals in Europe), and

as a ratio relative to normal (PT/Median Normal PT).

Normal PT levels vary from person to person. The median normal PT

(MNPT) from at least 30 healthy, warfarin-free individuals is determined

for each lot of reference reagent to which each strip lot is calibrated to

12.0 seconds (or a ratio of 1). This corresponds to an INR of 1.0. The

median PT is usually a good approximation of the geometric mean.3

Patient results in seconds are that which would be expected for a

reagent and instrument system with an International Sensitivity Index

(ISI) of 2.0. INRs derived from the CoaguChek System are a result of

calibration to a plain rabbit brain thromboplastin reagent tested on an

optical instrument having an ISI of about 2.0.

The physician must determine the best PT level depending on the reason

for anticoagulant treatment and how each individual responds to

treatment (based on Prothrombin Time). Each physician should establish

expected values for his or her patient population or individual patients.

In the field of prothrombin testing, variations in reaction mixture

composition, thromboplastin tissue type, and system sensitivity may

cause some variation in results when comparing results from different

laboratory methodologies on the same patient.4

Unusual Results

If the patient’s PT value seems unusually low or high and you have

performed the testing procedure correctly, run a control.

If the control is out of the acceptable range, the following can cause

unusually low or high results:

- Control used after expiration date.

- Foil pouch opened and strip not used within four minutes.

- Sealed foil pouch stored improperly.

- Foil pouch damaged.

- Maintenance and cleaning procedures have not been followed. See the

CoaguChek System User’s Manual for these procedures.

If the control is in the acceptable range, the system is working properly. If

the result does not match the clinical symptoms, repeat the patient test

to rule out procedural error. There are many reasons why the patient may

demonstrate unusual results. In the field of prothrombin testing, certain

drugs may affect PT results by affecting warfarin pharmacology. The

potential effect of a drug interaction with warfarin or the effect of

underlying diseases (e.g., liver disease, congestive heart failure) must be

considered when interpreting a result. Any unexpected results should

always be followed up with appropriate coagulation studies and inquiries

to define the cause of the unusual result.

Call Point of Care Technical Service Center at 1-800-428-4674, 24 hours

a day, if you have any questions.

Quality Control

Quality control testing ensures the user’s technique, integrity of the test

strips, and performance of the monitor and strips together. Daily control

testing is good laboratory practice and required by most states. Always

check with the appropriate licensing or accrediting bodies to ensure your

quality control program meets the established standards.

Frequency of Testing Requirements-Waived Testing:

• Daily Requirements:

Two levels of Electronic Quality Control or two levels of liquid quality

control (Cat. No. 7745) must be tested to verify proper monitor

performance.

• Additional Requirements:

1. Two levels of liquid controls must be tested and results must be

within the designated range for the following situations:

You open a new box of test strips

You suspect improper storage or handling of the strips

Patient PT results are unusually high or low

2. Two levels of Electronic Quality Control or two levels of liquid quality

control must be tested if the monitor is dropped or mishandled.

The results must be within the designated range.

Frequency of Testing Requirements-Moderate Complexity Testing

Daily quality control testing is good laboratory practice. It is also required

by most states and by CLIA ’88 regulations. Check with the appropriate

licensing or accrediting bodies to ensure that your quality control program

meets established standards.

• Daily Requirements

A two level Electronic Quality Control device (Cat. No. 2032155) or Liquid

Quality Controls may be tested to verify proper monitor performance.

• Additional Requirements

A Liquid Quality Control (Level 1 or 2) should be tested when:

1. A new shipment of test strips is received

2. A new lot number of strips is opened

3. Improper storage or handling of the strips is suspected

4. Patient PT results are unusually high or low

This testing is in addition to the daily EQC testing. The results must be

within the designated ranges.

Be sure to use the appropriate controls for your system: CoaguChek

System—Use Cat. No. 7745.

The CoaguChek System Controls are available from your local CoaguChek

System dealer or from Roche Diagnostics.

Control tests are performed in a similar way as blood tests, using the

CoaguChek System Control instead of blood. The control instructions

should be read before using the controls. The system is working properly

if the control value displayed by the monitor is within the acceptable

range for the control solution tested. The acceptable control range can

be found in the control package on the CoaguChek System Control

Values Sheet. If the value is not acceptable, see the CoaguChek Control

package insert instructions. Call Point of Care Technical Service Center

at 1-800-428-4674, 24 hours a day, 7 days a week if you have any

questions.

Limitations of Procedure

The CoaguChek Systems Test uses only fresh, capillary or venous whole

blood. Plasma or serum cannot be used.

Use only plastic syringes without anticoagulants or additives. Glass tubes

or syringes must not be used.

The blood drop must be a minimum of 10 µL in volume. Low sample

volume will cause a SAMPLE ERROR - REMOVE STRIP warning.

This test measures PT results in persons on warfarin-type (Coumadin®)

therapy. This test should not be used to monitor persons on heparin

therapy. In vitro studies showed the CoaguChek Systems Tests are

sensitive to levels of heparin over 0.15 U/mL.

When a patient is on intravenous infusion therapy, do not collect sample

from arm receiving infusion line.

Hematocrit ranges between 32-52% do not significantly affect test

results.

No interference was found in lipemic samples containing up to 500

mg/dL of triglycerides. Testing performed with in vitro-spiked samples

indicated bilirubin up to 20 mg/dL and hemolysis up to 500 mg/dL did

not significantly affect test results.

The presence of anti-phospholipid antibodies (APAs) such as Lupus!!!!!!!!!!!!!!!!!!

antibodies (LA) can potentially lead to prolonged clotting times, i.e.,

elevated INR values. A comparison to an APA-insensitive laboratory

method is recommended if the presence of APAs is known or suspected.5

Sources of error

If problems occur when performing tests, please check the following:

• Have you used a wrong Test Strip Code Chip? The first three

numbers after the lot symbol on the test strip pouch should match

the numbers on the Test Strip Code Chip.

• The test result may be affected by hematocrit values outside the

range 32% to 52%.

• In rare cases, patients with long clotting times (>8 INR, >33.9 sec)

may produce a test error. If test errors persist, results must be

confirmed with an alternative test method. Contact the patient's

physician.

• Have you performed the test in accordance with the User’s Manual

and this package insert?

• Have you used correctly stored test strips (see ”Storage and

Stability”)?

• Have you moved the test strip between sample application and the

display of the result? Do not touch or move the test strip after

having applied the drop of blood. Also, do not attempt to apply

additional blood to the test strip once a first drop has been applied

(no double-dosing). In either case the monitor displays an error

message and a measurement with a new test strip will be

necessary.

• Are the test strip guide and the door clean?

Performance Characteristics

Verified Clinical Range: In clinical trials, patients tested in the 9.6 to

33.9 second range (0.6 to 8.0 INR). Performance outside this range has

not been verified.

Sensitivity: The CoaguChek System is sensitive to deficiencies of Factors

II, V, VII, and X.!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Accuracy: The CoaguChek System was compared against the

CoaguChek Plus Protime Test System and the MLA 700 Analyzer. The

following accuracy data was obtained:

INR Scale Seconds Scale

Capillary Whole Blood Capillary Whole Blood

CoaguChek vs. CoaguChek Plus CoaguChek vs. CoaguChek Plus

n = 81 n = 81

y = 0.864x - 0.002 y = 0.945x - 0.1

r = 0.966 r = 0.970

Venous Whole Blood Venous Whole Blood

CoaguChek vs. CoaguChek Plus CoaguChek vs. CoaguChek Plus

n = 81 n = 81

y = 1.022x - 0.2 y = 1.033x - 0.8

r = 0.952 r = 0.962

Capillary Whole Blood Capillary Whole Blood

CoaguChek vs. MLA 700 CoaguChek vs. MLA 700

Plasma Reference Plasma Reference

n = 81 n = 81

y = 0.793x + 0.2 y = 0.825x + 1.6

r = 0.983 r = 0.985

Venous Whole Blood Venous Whole Blood

CoaguChek vs. MLA 700 CoaguChek vs. MLA 700

Plasma Reference Plasma Reference

n = 81 n = 81

y = 0.862x + 0.2 y = 0.859x + 1.3

r = 0.984 r = 0.985

CoaguChek CoaguChek

Venous vs. Capillary Venous vs. Capillary

n = 81 n = 81

y = 1.077x - 0.07 y = 1.036x - 0.2

r = 0.992 r = 0.995

Precision:

Within-Day

Commercial Control Material

INR Scale Seconds Scale

Level 1 Level 2 Level 1 Level 2

n 20 20 20 20

Mean 1.03 3.66 12.24 23.01

SD 0.05 0.48 0.33 1.43

CV% 4.56 12.98 2.70 6.23

Day-To-Day

Commercial Control Material

INR Scale Seconds Scale

Level 1 Level 2 Level 1 Level 2

n 20 20 20 20

n 48 48 48 48

Mean 1.07 3.72 12.56 23.19

SD 0.07 0.31 0.47 0.94

CV% 6.66 8.41 3.71 4.06

Whole Blood

(Precision of Patient Duplicate Measurements)

INR Scale Seconds Scale

Capillary Venous Capillary Venous

n 81 81 81 81

Mean 2.16 2.26 17.2 17.6

SD 0.11 0.10 0.37 0.33

CV% 5.23 4.44 2.17 1.89

Return Policy

If there is a problem with the CoaguChek Systems Tests, you may be

asked to return them, along with the Test Strip Code Chip, to Roche

Diagnostics. Before returning, call the Point of Care Technical Service

Center at 1-800-428-4674. You will be mailed a return authorization label

which must be put on the shipping carton. Packages received without

this label will be returned at your expense.

References

1 Plonsey R, Collin RE. Magnetic field in material bodies. In: Principles

and applications of electromagnetic fields. New York: McGraw-Hill Book

Co., p. 226-57, 1961.

2 Oberhardt BJ, Taylor M, Alkadi ZY, Dermott SC. Diagnostic assay system

for convenient monitoring of oral anticoagulant therapy {Abstract}.

Thromb Haemostas, 1989;62:327.

3 Loeliger EA, van den Besselaar AMHP and Lewis SM., Reliability and

clinical impact of the normalization of the prothrombin times in oral

anticoagulant control. Thromb Haemostas, 1985;53:148-154.

4 Kaatz SS, White RH, Hill J, Mascha E, Humphries JE, and Becker DM,

"Accuracy of Laboratory and Portable Monitor International Normalization

Ratio Determinations." Arch. Intern. Med. 1995;155:1861-1867.

5 Moll, S. and Ortel, TL “Monitoring Warfarin Therapy in Patients with

Lupus Anticoagulants.” Annals of Internal Medicine 1997;127:177-185.

Additional Information

Refer to the CoaguChek User’s Manual for additional information about your

system.

If you still have questions, call Point of Care Technical Service Center at

1-800-428-4674, 24 hours a day, 7 days a week.

CoaguChek™

Systems

FOR COAGUCHEK SYSTEM

This system (monitor and test strips) and its use are covered by one or more of the

following U.S. Patents: 4,849,340; 5,110,727; 5,164,598; 5,300,779; 5,522,255;

5,686,659; 5,710,622; 5,789,664; 5,792,944; 5,832,921; 5,886,252 and Des. 361,129.

The test strips are covered by U.S. Patent No. 5,488,816; and 5,975,153.

COAGUCHEK is a trademark of a Member of the Roche Group.

Coumadin is a trademark of DuPont Pharmaceutical Company.

Manufactured for:

Roche Diagnostics Corporation

9115 Hague Road,

Indianapolis, IN 46256

coaguchek.com

©2002 Roche Diagnostics. All rights reserved.

056194603-1202

12 Replies

oldestnewest
  • Hi there

    Our charity has found the majority of patients in the UK find the Coaguchek XS monitor very safe to use – the only caveat is if a patient has a positive result for one of the antiphospholipid antibody tests: the lupus anticoagulant. Here is a definitive statement from Roche Diagnostics explaining this.

    "ROCHE STATEMENT FOR SUITABILITY OF COAGUCHEK XS SELF-TESTING MONITOR FOR APS/HUGHES SYNDROME PATIENTS

    There is a warning on the pack inserts for the Coaguchek XS which states:

    “Antiphospholipid antibodies (APA) such as the Lupus Anticoagulant (LA) may falsely prolong coagulation times ie. they may cause false high INR values and false low quick values. Where APA are known to be present, it is imperative that a result be obtained using an APA-insensitive laboratory method for comparison”.

    This is reiterated on Roche’s website under the Frequently Asked Questions section:

    Are there interferences when testing with CoaguChek systems?

    •Polyglobulism: Hematocrit outside the standard range (25 - 55 %)

    •Lupus anticoagulant: INR abnormally high

    The presence of anti-phospholipid antibodies (APAs) such as Lupus antibodies (LA) can potentially lead to prolonged clotting times, i.e. elevated INR values. A comparison to an APA-insensitive laboratory method is recommended if the presence of APAs is known or suspected.

    Roche still recommends that the Coaguchek XS is suitable for APS patients as long as they have existing specialist advice, and understanding and support of their specialist.

    There are three tests which look for antiphospholipid antibodies: the anticardiolipin (aCL), the lupus anticoagulant (LA) and the anti-beta2-glycoprotein1. If a patient has a positive LA result, then Roche recommend that they continue having venous tests alongside the Coaguchek XS tests for three months to make sure the readings are stable.

    Verified by Matthew Johnson, Account Specialist, Point of Care and Ekaterina Lengefeld, Market Manager Roche Diagnotics. November 2010"

    If you personally do not feel comfortable with self-testing, then that is fine but I think you will find most patients are - however it's not for everyone and it sounds as though you wouldn't be happy doing it. If you are writing from the US, then please take up any issues with Roche over there as we are a UK registered charity and deal mainly with patients in the UK.

    Kate

  • I used a coagucheck for years withg no problems, it allowed me the flexibilty to do what I wanted to do including a fair amount of travel.

    The only reason I dont hgave one now is I cant afford the new XS Coagucheck!

  • I got half way down that lot and gave up..Phew! It reminded me of a passage in Kay Thackray's excellent book "Sticky Blood" which I am reading at the moment. She said about reading all the little leaflets in pill boxes.....

    "I never look at the side effects on the leaflet as if I don't read it I probably won't develop it! Amateur psychology but it often works for me! Study all those leaflets if you are the type that needs to know! We are all different after all."

    I think its sort of similar with this machine. Of course you must get it checked and calibrated so its in sync but for me the overwhelming aspect is the freedom it gives you - not having to sit in a Clinic for two hours for a two minute test sometimes twice a week! The ability to at least check your INR if you are getting odd symptoms so that then if you get a very high or low result you can contact somebody and say "hey! I need this checked out!".

    I would have killed for this when I was on warfarin, I got the healthcare pack and took it to the Clinic. Everyone was on my side except the people I needed to implement it and that was mainly because they had inaccurate views like the one posted above and had not bothered to educate themselves and nor were they prepared to.

    So at the end of the day if you are somebody who likes to be part of your treatment, to have some control and above all some freedom over your life so that "it" does not take over you, then its fantastic - a bit like injecting your own fragmin, your in control. If you are somebody who is happy to be under the total care of your medical team and trust their judgement and have the time to commit to them then thats fine too, you won't need it.

  • I just wanted to be sure the information is out there so that everyone has all the information before trusting this method. I would never consider home testing because I know several people that came dangerously close to death due to the false readings they had gotten from the machine.

    I must say that I do use this method but in a clinical setting with pharmacists, residents and Drs on hand for the 4 of us to decide if we have an out of range reading do we go for the arm draw to confirm or are the other reasons for the numbers to be out of range.

    I marked the areas that I was refering to with !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! for ease in locating the information.

  • I am shocked by the endorsement of these machines, many APSers have died and almost died because these machines gave inaccurate readings. If Roche as a company states that "it is imperative that a result be obtained using an APA-insensitive laboratory method for comparison" what is the point in getting a self tested INR then having to go to the lab anyhow?

    I don't agree with suing for stupidity but I hope someone does sue for the advocation of these machines in a group of people who have enough suffering without having to have suffer further after a stroke ruins their life cause their INR was monitored on one of these machines! It is ridiculous how Roche will not put a warning on the exterior of the box sayiing the coag system is not recommended for APS patients, while they will put it in the fine print at the end of their information brochure. Its not like there are not 100 million other users out there that can't use it, APS is not that common and how many patients would they lose? not many, but on that note, they produce these machines to ''save lives" but they are risking the lives of a certain group of people ridiculous.....

    I travel alot, I get bloods done while travelling and email my clinic who then doses me accordingly....

    I am truly shocked to know a "charity" for a certain syndrome endorses machines that could potentially kill their patients. What does it get from Roche to endorse these machines one should ask themselves?

  • Beck - First of all these machines are NICE approved. Secondly Roche will not even sell you a machine unless you are going to use it in full collaboration of a anticoagulation Clinic. In other words they check the readings if there is a need.

    It states that the readings can be up to 0.5 difference so if I was using a machine and I got a test that stated my INR was ANYTHING below 3 I would get a venus check done! It still saves me from having to run to the Doctors and the Clinic for routine tests all the time.

    HSF are a wonderful Charity that have done so much to raise the awareness of this disease. They would do nothing that would not be in the best interests of APS patients. Prof Hughes is an advocate of self testing. Suggesting that these machines can potentially hurt somebody is being very dramatic and even sillier is the notion that HSF would profit from anything along the lines you suggest.

  • Can you provide the links to back up your statement, as I conducted a search of the NICE web page and can find no evidence of their endorsement of home test INR machines.

    I can find the NHS evaluation Report 06024

    CoaguChek™XS system

    June

    2006

    and you will find a disclaimer on page 21 and note the date of the evaluation being completed in 2006

  • topix.com/forum/drug/coumad...

    dailystrength.org/c/Deep_Ve... . previous links are patients that dont have APS!

    apsno2homeinr.blogspot.com/

    accessdata.fda.gov/scripts/...

    ?www.accessdata.fda.gov/?sc...

    ?www.accessdata.fda.gov/?sc...

    MAUDE Adverse Event Report

    accessdata.fda.gov

    I only want to provide information so everyone is making informed decisions!

  • Grant - You live in the USA, my understanding is that the machines used over there are different to those used here and the way things are done there are also different. Perhaps you should concentrate on things on your side of the pond!

    If you insist on trying to scare monger I will find the information that you want.

  • I don't very often make a comment but I feel it is really important to say that I had secondary DVTs due to the CoaguChek machine giving false readings of my levels, and I live in the UK. When we did check the machine readings with the lab results they were considerably different. For this reason I only have venous tests checked by the lab. However, I really wish that Roche could find a resolution to this problem as my veins are suffering quite badly now. I could continue to use the machine but what is the point if I have to have every reading checked with a lab result? I do not want to scare anyone but I feel it is imperative that people are aware that this can be a real problem. Best wishes to you all.

  • I hate to blow up your bubble, but they are the same machines. The lectures are the same, they are trained the same, they are told in their contract NOT to disclose anything unless specifically asked...that includes APS. They do not care about YOU, they care about their bottom line. (Money, if you don't understand how large corps works. How much does their CEO make a year?) Remember, in their latest lecture, that they said they were the leading seller of these great machines. Leading doesn't mean honest.

    Why does it matter what country you are from. Both countries are having issues with these machines. Some of them are in denial of those problems. Some of them have to protect their sponsors. Some of them are truly lucky and the machine works fine for them - and that is great. What is wrong with educating people? This isn't fear mongering, this is education and a hey, make sure you do your comparisons. Make sure when you get these machines that you compare with a vein draw until the point you can not longer return it. You not feeling right, the number is reading high, listen to yourself and not the machine and get it checked by vein draw. What is wrong with being proactive?

    It is unacceptable of a charity to turn people away because they are not from the UK. I am sure that is not in you mission statement.

    grantlg provided some great resources. Read them. I am going to provide some more. Ignorance in this case may kill you.

    To the person scoffing that the insert was made in 2006. It costs big money to redo those and convert them in all the languages for the different countries they sell them in. They are only redo when there are changes. There have been no changes.

    fdanews.com/newsletter/arti...

    accessdata.fda.gov/scripts/...

    apsno2homeinr.blogspot.com/

    hemosense.com/docs/5500259_...

    health.groups.yahoo.com/gro... registration required.

    topix.com/forum/drug/coumad... Nope, these people don't have APS either.

    dailystrength.org/c/Deep_Ve... Doesn't have APS either.

    apsfa.org/docs/FB5933_0307.pdf Hemochron Jr, their disclaimer was finally added when patients, doctors & the FDA pushed it to be added because people were having strokes and other major problems..including death.

    apsfa.org/docs/IR5259_0307.pdf

    apsfa.org/docs/XS%20Strip%2...

    "The presence of anti-phospholipid antibodies (APAs) such as Lupus antibodies (LA) can potentially lead to prolonged clotting times, i.e., elevated INR values. A comparison to an APA-insensitive laboratory method is recommended if the presence of APAs is known or suspected.1"

    "such as" is an EXAMPLE. It does not say ONLY. Please explain those that do not have APS having these issues?

    I am sure I will be removed for stating my opinion and facts that will just prove a few other points that people have made in this thread regarding this charity. I am totally horrified that people from another countries are being turned away when at one point in time they were more than happy to take money from the US.

    You guys honestly feel they machine machines special for you?

    Oh, you may also want to read this too: The Antiphospholipid Story. It dates back to 1906: apsfa.org/docs/The%20Antiph...

  • Hi all,

    Firstly may I say that as the moderator messages will only be deletedif it is deamed to be offensive ,which at the moment you are treading a fine line. I do agree that people should have a say but also you need to understand that some of your information will be a little over the top as we have members that have and are using these machines successfull. In regards to funds being given to hsf no charity would do this and I feel very sad that you think this and would try to insinuate this with out proof so please refraine from writing such slander.

    Regarding this forum, this group is open to all people from across the world. What Kate was saying was that if you have a specific issue over these machines you need to take it up with your local aps charity as hsf covers the UK. I would again point out that even though this is a hsf forum they happy to help it point any forum member as long as they do not slander people or organisations with out proof and do not start attacking people.

    If you would like to discuss this more please contact me otherwise everyone can now leave this as the last message so people see both sides and can make there own minds without being attacked or pushed either way.

    Paddy

    HSF HU Moderator

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