How medical diagnostics giant Abbott ... - Prostate Cancer N...

Prostate Cancer Network

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How medical diagnostics giant Abbott flooded the market with faulty machinery

Justfor_
Justfor_

It never stops amazing me how people take important treatment decisions based on isolated-sparse PSA results. Not to mention the "golden" rule: "Use the same lab".

archyde.com/how-medical-dia...

25 Replies

Hey Justfor_!

According to my security the link you supplied is red hot!

Currumpaw

Justfor_
Justfor_ in reply to Currumpaw

Hi Currumpaw,

Can you be more specific about "red hot!". Which piece of security software or website listing detected the purported security threat and what exactly was this (spam, blacklisted site, fishing, trojan, other).

After your post, I looked at it, yet found nothing. The archyde.com domain looks 100% legitimate:

sitecheck.sucuri.net/result...

ssltrust.com.au/ssl-tools/w...

As to the validity of the article, FDA has issued 3 specific recalls for this series (alinity) of medical device:

accessdata.fda.gov/scripts/...

I had no problem with computer security for the article. But the headline seems to promise more info than the article actually gives.

Justfor_
Justfor_ in reply to jimreilly

Ok, but this can't be refered to as a security issue.

Hidden
Hidden

One would think that the huge government agencies would actually do their jobs. These devices like all medical devices must be validated. How did they pass the validation tests? That is the real issue.

Justfor_
Justfor_ in reply to Hidden

The same way by which VW passed their automotive motor emissions test. The good thing is that they (sometimes) get caught.

Hidden
Hidden in reply to Justfor_

Not quite but I'm not going to debate the differences.I think it's sufficient to say that before a company can put a product on the market it must get an approval from said government, the government has significant risks in validating the claims of the product.

Currumpaw
Currumpaw in reply to Justfor_

Hey Justfor_

The VW analogy is succinct!

I'll trust my security though. The chatter from those that accessed the link is sufficient.

I have had PSA tests four days apart. Same lab. Discrepancy of 4. A friend in Georgia had a discrepancy within days of over 7. Same lab.

Currumpaw

Hidden
Hidden in reply to Currumpaw

For the record the VW analogy is not succinct. Cars are not validated systems. Testing and validation are not the same.

Currumpaw
Currumpaw in reply to Hidden

Hey XPO1,

Terse and to the point? The inspection sticker on a vehicle's windshield doesn't ----validate---that the vehicle has successfully passed emissions testing? In the past, the rubber stamp some companies used to show that the holder of a parking ticket with the time of entry on it was stamped, "VALIDATED" meaning that the owner of the parking lot would turn it in to the company to be reimbursed.

I understand that testing is done to validate that something does what is acceptable and expected. Like car emissions?

Currumpaw

Hidden
Hidden in reply to Currumpaw

One of the beautiful things about these type of sites is the manifold of people commenting on things they have no clue about. The term "validate" has a specific meaning in software testing. You should familiarize yourself with a term before responding with utter nonsense.

Hidden
Hidden in reply to Currumpaw

And VWs passed emissions test.That was the scandal. The software knew when an emissions test was being conducted and the car emitted less.

Justfor_
Justfor_ in reply to Currumpaw

Depends on the actual value. Discrepancy of 4 into 20 is 20%, border line of intra-lab plus diurnal PSA allowable variance. Discrepancy of 4 into 100 is 4%, kudos to the lab and your body.

Currumpaw
Currumpaw in reply to Justfor_

Hey Justfor_,

My friend's PSA result was over 100% in error.

My onco was concerned enough about my increase to order another PSA before our regular "visit". My onco's statement about the discrepancy between the two PSA test results in four days was that what happened to me is why he doesn't rely on PSA testing which can be erratic. I changed nothing that I do.

Currumpaw

Justfor_
Justfor_ in reply to Currumpaw

My first PSA test, 6 weeks after RP was 0.02. Next one, at the 3 months mark was 0.11, same lab. I asked the lab to send the remainder of the draw to a third lab for consistency testing. It came back at 0.13. For the 4 monthly tests that followed using 3 other labs it was again 0.02. I can only attribute the 600% error to contamination of the blood flask (don't ask me how -have no rational explanation). The inter-lab 0.11 - 0.13, ~20% discrepancy is within the acceptable range.

Currumpaw
Currumpaw in reply to Justfor_

Hey Justfor_,

My friend is on AS. His went from a 5.XX to a 14.XX! I assured him that he tests too frequently to--freak! Not likely things happen that quickly. The results of the retest two days later lowered his blood pressure and heart rate!

Currumpaw

Justfor_
Justfor_ in reply to Currumpaw

20 months after my RP I have in my spreadsheet 16 valid PSA entries (the one at 3 months was discarded). By extrapolation I anticipated a 0.07 for December past. It came as 0.08. One week later counter test with the second lab I alternatively use. Not freaked at all when it came at .11. Yet, I needed to know. So, next day a third (new) lab found 0.104. I am currently making an experiment with Neem Leaves after Nal. Based on my past data if my next lab is 0.06 or lower then with a certainty of 95% I can say that it did good. On the flip side 0.15 or higher denotes the exact opposite.

If you understand the number tolerances, you simply don't freak. If you think that the computer prints out is always correct and don't know what SISO stands for, then you do. Simple as that!

Hidden
Hidden in reply to Justfor_

Do you know for fact the item being tested for is evenly distributed in the sample?I'm not a lab technician nor experienced with the equipment but I think the homogeneity of the sample used for testing could also impact results.

Justfor_
Justfor_ in reply to Hidden

Yes, this can be a parameter as well as the evaporation of the blood plasma while kept in the container thus elevating density (remember we have a weight/volume unit). On the other hand, PSA has a half life of 3-3.5 days and one day between tests is not something negligible. All these errors interact, some counter-acting others which brings us back to square number one:

Do NOT take important treatment decisions based on isolated-sparse PSA results.

Hidden
Hidden in reply to Justfor_

No argument there

Hidden
Hidden in reply to Justfor_

On the other hand, I just worry about maintaining <0.1 readings. As long as I get that, I'm not concerned about the issues you seemed to be occupied with.

Justfor_
Justfor_ in reply to Hidden

Probably because you have not any treatment decisions pending. You must be in a stable state with what you are doing. My case is a rising slope where I need to know the right timing for a compromise PSMA PET/CT prior to sRT. If this happens a couple of months earlier or later it doesn't change the course, only the timetable. Otherwise a PSA test costs just 14Euros. I can afford it. The supplements I take cost more than 10 times this.

Hidden
Hidden in reply to Justfor_

Since you had an RP, what treatment decisions require anything less than 0.1.Your doctors probably aren't concerned. I don't think any scans will help.

But it's your life and gray hair so have at it.

I got to: "You have 89.98% of this article left to read. The rest is for subscribers only." - can you tell us the hidden part?

Justfor_
Justfor_ in reply to Don_1213

I neither got passed this point, but also hadn't any need to read any deeper. As a retired engineer I have seen during my professional life the proliferation of such paradigms.

IMO there are two reasons for this:

Up to the 60s, maybe the early 70s, the top ranks of technology companies were populated by engineers. The were good at making reliable pieces of equipment, but not so good in making money. The big ones of my student years have all gone bankrupt. RCA, Motorola, just to mention two. Consequently, engineers were demoted and "market" oriented people took the helm of the big companies of today (no names here).

The second thing that changed the scenery was the advent and the subsequent proliferation of the computer. Younger generations have grown up with the dogma that if something comes out from a computer, it must be correct. I mentioned in another thread that the volume of my prostate after an mpMRI was quoted as 59.465cc. Yes, with 3 decimal points!!! After prostatectomy it was measured to 35 cc (no decimal points).

My point for bringing into light this article was to advise members here to always verify and counter check any figures obtained prior to important treatment decisions. This is what I personally do.

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