BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 15194478 · Received August 9, 2022

    Report

    Report Number
    1823260-2022-02380
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    June 29, 2022
    Report Date
    September 6, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    04015630945689
    PMA / PMN Number
    K062925
    Removal / Correction Number
    RES 86951
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE METER IS PROVIDED TO U.S. CUSTOMERS PRE-SET TO THE MEASURING UNIT INR. THERE ARE TWO ADDITIONAL MEASURING UNITS ON THE METER: %QUICK (%Q) AND SECONDS (SEC). IN THE U.S., THE MOST ACCEPTED UNIT OF MEASURE IS INR. ROCHE HAS COMMUNICATED TO ALL IMPACTED CUSTOMERS INSTRUCTIONS ON HOW TO CONFIRM RESULTS ARE DISPLAYED IN THE MEASURING UNIT INR AND THE STEPS TO TAKE TO CHANGE THE MEASURING UNITS BACK TO INR IF THE METER IS DISPLAYING THE UNITS SEC OR %Q. IT HAS ALSO BEEN COMMUNICATED TO ALL IMPACTED CUSTOMERS HOW TO SET THE METER TIME AND DATE. THE STRIP LOT THE CUSTOMER WAS USING (LOT 57790222), INCLUDED UPDATED LABELING AND STATES: "CAUTION: THE COAGUCHEK XS METER IS PRE-SET TO DISPLAY RESULTS IN THE INTERNATIONAL NORMALIZED RATIO (INR). THE METER IS ALSO CAPABLE OF DISPLAYING RESULTS IN SECONDS (DISPLAYED ON METER AS SEC) AND % QUICK (DISPLAYED ON METER AS %Q) (A MEASURING UNIT USED MAINLY BY HEALTHCARE PROFESSIONALS IN EUROPE). WHEN TESTING FOR INR, YOU MUST CONFIRM THAT THE MEASURED RESULT IS DISPLAYED IN INR PRIOR TO USING THE RESULT AND WHENEVER THE DATE AND TIME SETTINGS ARE MODIFIED. TO RESET THE MEASURING UNIT TO INR, FOLLOW THE INSTRUCTIONS IN THE TESTING A BLOOD SAMPLE SECTION OF THE COAGUCHEK XS SYSTEM USER MANUAL FOR SELF-TESTING, VERSION 8.0 AND HIGHER OR CALL THE ROCHE DIAGNOSTICS TECHNICAL SERVICE CENTER AT 1-800-428-4674 FOR ASSISTANCE, IF THE RESULT IS DISPLAYED IN %Q OR SEC." DURING THE CALL, THE CUSTOMER WAS ASSISTED WITH SETTING THE CORRECT DATE, TIME, AND UNIT OF MEASURE ON THE METER.

    Additional Manufacturer Narrative · 0

    THE EVALUATION RESULT AND EVALUATION CONCLUSION CODES HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    IT WAS ALLEGED THAT A PATIENT TESTING WITH COAGUCHEK XS METER SERIAL NUMBER (B)(4)REPORTED RESULTS IN UNITS OF INR WHEN THE DEVICE WAS DISPLAYING UNITS IN % QUICK. THE DATE SETTING OF THE METER WAS ALSO SET INCORRECTLY BY THE USER. ACCORDING TO THE METER'S PATIENT RESULT MEMORY, THE FOLLOWING RESULTS WERE REPORTEDLY THE MOST RECENT RESULTS MEASURED (THE DATE SETTING WAS INCORRECT ON THE METER, SO THE ACTUAL DATES ARE UNKNOWN): 21 % QUICK (2.5 INR) ON "(B)(6) 2003"; 17 % QUICK (3.0 INR) ON "(B)(6) 2003"; 8 % QUICK (5.9 INR) ON "(B)(6) 2003"; 8 % QUICK (5.8 INR) ON "(B)(6) 2003"; 11 % QUICK (4.5 INR) ON "(B)(6) 2003"; 12 % QUICK (4.1 INR) ON "(B)(6) 2003"; 15 % QUICK (3.4 INR) ON "(B)(6) 2003". THE PATIENT ALLEGEDLY REPORTED RESULTS AS INR RESULTS WHEN THE RESULTS WERE ACTUALLY IN UNITS OF % QUICK. THE PATIENT'S WARFARIN DOSE WAS ALLEGEDLY INCREASED STARTING IN (B)(6) (DATE UNKNOWN). THE PATIENT ALLEGEDLY HAD MULTIPLE NOSEBLEEDS AND THE PATIENT HAD CAUTERIZATION TO STOP THE NOSEBLEEDS AT THE END OF (B)(6) 2022. THE SPECIFIC DATE OF THE EVENT IS NOT KNOWN. AT 8:15 A.M. ON (B)(6) 2022, THE PATIENT ALLEGEDLY HAD A METER VALUE OF 12 % QUICK (4.3 INR). WITHIN MINUTES OF THIS FIRST TEST ON (B)(6) 2022, THE PATIENT WAS ALLEGEDLY TESTED USING THE DOCTOR'S ROCHE METER (UNKNOWN MODEL AND SERIAL NUMBER), RESULTING IN A VALUE OF 4.5 INR. BASED ON THE DOCTOR'S METER RESULT OF 4.5 INR, THE PATIENT'S WARFARIN MEDICATION WAS ALLEGEDLY STOPPED FOR ONE DAY AND THE NEXT DAY, THE PATIENT TOOK HALF A DOSE. THE PATIENT'S THERAPEUTIC RANGE IS REPORTED TO BE 2.3 - 2.5 INR. THE PATIENT'S TESTING INTERVAL IS REPORTED TO BE EVERY 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2348043 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS NA NA 04015630945689

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention LUTEIN| MAGNESIUM| MYCOPHENOLATE| PREDNISONE| TACROLIMUS| WARFARIN