ATTENTION COAGUCHEK CUSTOMERS

ATTENTION COAGUCHEK CUSTOMERS

In order to ensure that your CoaguChek values can be compared to values of other devices (e.g. laboratory systems, Point-of-Care systems in your GP office/Coagulation clinic) Roche calibrate their test strips against the standard from the World-Health-Organization (WHO).

This standard was renewed in 2016. Although manufacturers are not obliged to standardise against the newest standard, as a pioneer for the monitoring of so called “Blood Thinners” Roche Diagnostics decided to do so.

Roche Diagnostics has received an increase in complaints regarding deviations against laboratory methods during the last weeks. Therefore, Roche initiated an in-depth analysis in order to determine the reasons for the observed differences.


The results of the analysis were:


  • For values between 0.8 and 4.5 INR: No significant differences are seen and your CoaguChek is reliable.
  • For values above 4.5 INR: Greater than expected deviations to the laboratory methods were seen.


 

What does this mean to me as a patient self tester?

Each patient has a so called “therapeutic range” she/he should be compliant to. The therapeutic range is defined by the indication you are receiving “Blood Thinners” (e.g. Atrial fibrillation, heart valve, VTE etc.) for. None of the medically used therapeutic ranges exceed the above mentioned value of INR 4.5. Therefore, your system is delivering reliable results for your relevant therapeutic range. However, according to the package insert you should contact your physician every time you are out of your therapeutic range:


CoaguChek XS PT Test PST:

“If the measured result is outside the therapeutic range specified by your treating physician, repeat the test. If the

result is still outside the therapeutic range immediately contact your physician and ask for the appropriate

(anticoagulant) measures to take.”


Therefore, the limitation caused by this issue should be minimal, except of the fact that you should ask your health care professional for a laboratory cross-check for values above 4.5 INR.

 

What are the affected test strip lots?

The following lot numbers may be used up to an INR of 4.5. If the values exceed an INR of 4.5, please contact your health care professional.


Product Number

07671679190

07671687019

Lot Number (only valid up to 4.5 INR)

#272167 - 334498

 

Will this limitation be forever?

No – Roche Diagnostics has already started to produce new CoaguChek test strips, which will not have this limitation anymore and those strips will be available from mid of October 2018 as follows:


Product Code

07671679190

07671687019

Lot Number

≥334499 (S_344)

≥334499 (S_344)

ETA for stock in NZ

October 2018

November 2018

 

How do I recognise which CoaguChek test strip lot/code chip number I have?

The lot number is printed on the label, which is applied to the test strip box at manufacturing:

The code chip number is printed on the code chips (as shown below).

 

Who can I call for more advice?

Please contact your Roche Diagnostics CoaguChek Support

Phone: 0508 69 5433

Email: new_zealand.coaguchek@roche.com


We apologise for any inconvenience caused by this issue to you.






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