Problems with Coaguchek: I spoke to the... - Hughes Syndrome -...

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Problems with Coaguchek

Jumper99
Jumper99

I spoke to the lady on the Coaguchek helpline this morning about the discrepancies between the machine readings compared to venous sample readings. Although a little reluctant to admit there was a problem at first, I did find out that they are investigating but have not found the cause of any problem yet. She said it was happening with more than one batch, not just 311 which is the one I have.

She is going to send me some more strips and assured me that the fault was very unlikely to be with the actual machine. I did explain that the problem was endangering people’s lives.

She will also provide a form for me to complete and an address label to return the ones I have left in batch 311, although I have to provide my own Jiffy bag!

Not much help but at least you can get more strips from a different batch.

20 Replies
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HollyHeski
HollyHeskiAdministrator

One step forward, two back!!

At least they admitted fault - if not take responsibility for peoples lives. This has been going on for a while now - let's hope everything gets sorted soon and confidence can be restored.

Thanks for posting and keeping us in the loop.

LesJames
LesJames in reply to HollyHeski

I test with coaguchek, and have done for over 10 years. the discrepancy with my machine and the venous check I do very month is 0.4. My warfarin clinic are happy to accept this and ask, as I have said to check it with a venous sample once a month. I suppose if it is the strips that are at fault, maybe I should check every batch of strips. Hope you get it sorted.

Hidden
Hidden

Hi! Did you speak to someone in the UK? My conversation yielded NO answer in the US.

KellyInTexas
KellyInTexasAdministrator in reply to Hidden

Which Dept did you speak with? Technical? Had they heard of the issue before your call?

Jumper99
Jumper99 in reply to Hidden

Yes, I’m in the UK although the lady I spoke to did not sound British but had a European accent.

UPDATE:

Bad news so far. I got some new strips from Roche, Batch 334. We have now done 2 comparisons. The first one was 0.4 different (my machine was higher than venous) and the one today was 0.5 different (again home testing showed a higher reading). This is the limit of what my anticoagulation dept will accept. It is also much greater than the variances I’ve had over the previous 15 years when the greatest difference was 0.2. As my INR is running just below range then we will do a third comparison next week.

But I am so lost without my home testing machine to rely on. I don’t know what to do next other than talk to Roche again.

KellyInTexas
KellyInTexasAdministrator

I’m having a lot of trouble. I called my supplier this morning. ( independent from Roche.) I told him the issues in the UK.

He was not aware, but appreciated the heads up. Here is what I found out from him:

The manufacturing plant for strips is in Germany for the strips. ( they ship out from there to states and rest of Europe. Possibly even to Asia.)

He’s going to send me 48 strips with code number 325. I’ll begin them in about 3 weeks.

Today my FP value was 7.3 ( last night in the 5’s)

Vein value was 4.7. (

Last week I was 7.1

Vein 4.5 ( spot on for me.)

Something is clearly wrong.

I’m thinking to just get a port because I cave clots in the superficials in the veins where I’m drawn that come and go making it very difficult to draw this often.

Roche is based in Basel in Switzerland although deals worldwide with its diagnostics and pharmaceuticals. Basel I think is near the borders of Switzerland with Germany and France so may well have factories in Germany.

Your new batch number 325 will be nearer than my new ones to the batch 311 which has been noted as one of the bad batches. So I will be very interested to see what happens.

I will phone Roche again and tell them I still have probems with my new batch and see what they say.

KellyInTexas
KellyInTexasAdministrator in reply to Jumper99

Yes, we are Swiss citizens actually. (American also.) possibly the factory is in Switzerland and my rep made a mistake and told me Germany. But yes. Roche is Swiss. French Swiss.

Hi do you know the problems are with test strips in the in range machine too? Or just the older xs machine..

All very worrying. I have not long had my machine but worried about using it now.

Jumper99
Jumper99 in reply to Lind8

They are different strips so I don’t know about them. Did you not check your machine when you first got it? If you’re using the same batch of strips then you have checked them when checking the machine.

NEXT UPDATE

Today’s comparison was a disaster! Venous test was 2.9 but my machine read 3.8 Totally unacceptable. And yet another venous sample needed in a weeks time. I will try phoning Roche tomorrow.

KellyInTexas
KellyInTexasAdministrator

I’ve just come from my vascular surgeons office. I’m beyond upset. Both arms are in Deep vein thrombosis now- from arm pit to elbow- entire length of both brachials. They are in resolution stage- about three weeks old.

It’s partially because of these strips. How can I manage my INR like this?

I’m so sorry you are having such problems Kelly. I wish I had an answer for you.

My anticoagulation clinic say that Roche may have changed the reagents on their strips which might change if we can rely on them or not. It’s interesting that this change is not long after the introduction of a new machine, I’m thinking that might be a cause of changing reagents so that they use the same reagents for both machines. I will ask about any changes.

KellyInTexas
KellyInTexasAdministrator in reply to Jumper99

I meant to reply to you directly about reagents- check general reply below. Sorry about that...

KellyInTexas
KellyInTexasAdministrator

I spoke with Roche about three months ago- they were using Dade Innovan. My hospital uses Neoplastin. ( Neoplastin is supposed to be a universal one.)

Next Update:

I just spoke to Roche’s technical helpline. They were not at all helpful. They said that the reagents used have not changed. For all other questions they refused to comment as there is still an ongoing investigation. She wouldn’t even tell me if it affects the new machine as well as the XS machine.

So I said I would have to stop using the machine. Her reply was that was up to me if that was the decision I made from the information she had given me! I told her it wasn’t up to me, it was the fact that their machines were now unreliable and were putting my life in danger. It got me nowhere but I did feel I had to make the point that it was endangering lives. I can’t understand why this isn’t getting more publicity as it is so serious.

KellyInTexas
KellyInTexasAdministrator

I went to my hospital lab today.

My personal coaguchek # 317= 6.2

Hospital coaguchek #299= 5.6

Vein value= 4.67

( all drawn in tandem by same nurse. )

KellyInTexas
KellyInTexasAdministrator

Good evening! I told you I would let you know when I began my new batch of strips. I began on Aug 31st. Today was the first time I parallel tested.

They are faulty as well.

Batch ( code#) 325

Lot # 30497311

Today’s finger prick value: 6.2

Vein value: 4.09

Yesterday’s finger prick value: 5.8 ( horrible migraine and blood clotting symptoms.) if I fall below 4.0 this happens. I should have gone in for a vein draw but I was honestly too sick to drive.

I have had the same difference as Kelly with Coaguchek XS. A comparison over 2.3.

We both need an INR around 4.0 and when the INR is higher the difference is also bigger.

I have talked to Roche and they admit this trouble they have since one year or something like that.

My coagulation clinic did not want me to use that machine so I have switched to another. I think I am perhaps not allowed to say the name here of the new machine I use. There is still a difference but not that big as with CoaguChek XS.

Kerstin in Stockholm

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