CoaguChek XS Meters — Possible Misinterpretation of Displayed Measuring Units

[MdaPA]

For those who use a CoaguChek XS meter, my wife received the below letter and document from RemoteINR re: an Urgent Medical Device Update (UMDC) issued by Roche.

The information contained in the UDMC outlines specific instances in which patients could inadvertently change the measurement settings. It also outlines ways to correct those settings.

UMDC-alert-cover-letter-Patient.pdf
TP-01142-coaguchek-patient-FINAL.pdf

 

[pellicle]

Frankly I'm surprised, must be some person didn't even read the quick start guide and or no training.

It's a bit tragic when you have to send out a letter like that because of that

 

[Sheenas7]

Hi Pellicle,
Is that letter over a patient misuse of the meter for Inr? Not following directions? Changing results?
I assume it’s not an alert of malfunction to us all?
Thank you

 

[MdaPA]

I assume it’s not an alert of malfunction to us all?

I see no indication of a malfunction in the provided documentation. The cover letter

outlines specific instances in which patients could inadvertently change the measurement settings. It also outlines ways to correct those settings.

However, it looks like the user manual is incomplete and Roche is subsequently making some updates.

The current User Manual for your meter does not contain instructions on how to change measuring units on the CoaguChek XS PST meter. This UMDC provides instructions on how to ensure your meter is displaying INR results. Roche is updating the User Manual and the package insert labeling for the test strips accordingly.

 

[Sheenas7]

I see no indication of a malfunction in the provided documentation. The cover letter

However, it looks like the user manual is incomplete and Roche is subsequently making some updates.

Thank you for clarification.