FDA Adverse Event Injury Summary report: N

COAGUCHECK XS

MDR report key: 20853911 · Received December 4, 2024

Report

Report Number
MW5163201
Event Type
Injury
Date Received
December 4, 2024
Date of Event
December 2, 2024
Report Date
December 2, 2024
Manufacturer
ROCHE DIAGNOSTICS GMBH
Product Code
GJS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAVE BEEN A USER OF INR TESTING DEVICE FROM REMOTE CARDIAC SERVICES (RCS) FOR THE PAST 15-20 YEARS. I USE THEIR COAGUCHECK XS DEVICE THAT APPEARS TO BE MANUFACTURED BY ROCHE DIAGNOSTICS. IN THE PAST YEAR, I HAVE HAD TO REQUEST REPLACEMENT OF 4 DEVICES ALL RELATED TO THE SAME ISSUE, WHERE THE DEVICE WOULD SUDDENLY STOP WORKING. IN ALL INSTANCES, THE ISSUE WAS THAT THE AAA BATTERIES SUPPLIED BY THE MANUFACTURER WOULD LEAK / BLOW OUT. AND SOMEHOW THE DEVICE WOULD BECOME INOPERABLE EVEN AFTER I TRY TO REPLACE WITH NEW BATTERIES. I SUSPECT IT IS A DEVICE ERROR AS OTHERWISE REPLACING BATTERIES SHOULD SOLVE THE ISSUE BUT NOT HERE. PUTTING ASIDE THE INCONVENIENCE OF HAVING TO CALL AND REPLACE THE DEVICE TIME AND AGAIN, MY MAJOR CONCERN IS THE PURPOSE OF HAVING THIS DEVICE IS DEFEATED AS I AM UNABLE TO TRACK AND REPORT MY RESULTS TO MY DOCTOR ON A WEEKLY BASIS AS I AM REQUIRED TO. I TAKE WARFARIN DAILY, AND IT IS ESSENTIAL THAT I REPORT MY RESULTS EVERY WEEK, OTHERWISE I COULD BE AT RISK OF SERIOUS BODILY INJURY OR DEATH IF THE INR IS OUT OF PRESCRIBED RANGE. I COULD NOT TEST AS THE METER WASN'T WORKING. I CALLED RCS TO REPORT THE PROBLEM AND REQUEST A REPLACEMENT METER. THEY HAD ACKNOWLEDGED DURING AN EARLIER CALL (THE LAST TIME THIS HAPPENED) THAT THIS IS A KNOWN ISSUE, AND THEY ARE WORKING TO RESOLVE IT. BUT TO MY SURPRISE, THEY TOLD ME TODAY THAT THIS IS A PROBLEM UNIQUE TO ME WHICH DOESN'T MAKE ANY SENSE AS THE DEVICE HAS ALWAYS BEEN IN THE SAME ENVIRONMENT IN THE SAME LOCATION FOR THE PAST 9 YEARS. SINCE RCS IS UNWILLING TO HELP, AND GIVEN THE GRAVITY OF THE PROBLEM, I AM SEEKING YOUR HELP IN INVESTIGATING THIS MATTER. REFERENCE REPORT# MW5163198, MW5163199, MW5163200.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2289682 COAGUCHECK XS TEST, TIME, PROTHROMBIN GJS ROCHE DIAGNOSTICS GMBH 04837738

Patients

Seq Age Sex Outcome Treatment
1 44 YR Male Required Intervention| O VITAMIN B12| VITAMIN D| WARFARIN