BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK ® XS SYSTEM

    MDR report key: 15321807 · Received August 30, 2022

    Report

    Report Number
    1823260-2022-02639
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    August 1, 2022
    Report Date
    September 22, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    UDI-DI
    00365702125100
    PMA / PMN Number
    K062925
    Removal / Correction Number
    RES 86951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER OCCUPATION: OCCUPATION IS PATIENT/CONSUMER (PATIENT'S WIFE). 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.

    Additional Manufacturer Narrative · 0

    CLARIFICATION WAS RECEIVED THAT ON THE FOLLOW-UP CALL THE METER WAS ALREADY SET TO THE CORRECT UNITS (INR). THE REPORTER REMEMBERED RECEIVING A LETTER ABOUT THIS ISSUE AND WANTED TO MAKE SURE THERE WAS NO ISSUE WITH THE METER.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED THEY COULD NOT FIND INSTRUCTIONS IN THE USER MANUAL FOR CHANGING THE UNIT OF MEASURE ON THE COAGUCHEK XS METER. THEY ALSO MENTIONED GETTING RESULTS IN SECONDS (SEC). ON A FOLLOW-UP CALL, THE RESULT PULLED FROM THE METER MEMORY WAS 2.3 INR WITH AN UNKNOWN STRIP LOT ON 11-JAN-2022. THE CALL AGENT REVIEWED HOW TO CHANGE THE UNIT OF MEASURE ON THE METER. AT THE TIME OF THE FOLLOW-UP CALL, THE USER'S METER WAS FUNCTIONING PROPERLY AND WAS CORRECTLY SET TO INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144132 COAGUCHEK ® XS SYSTEM PROTHROMBIN TIME MONITOR GJS ROCHE DIAGNOSTICS XS PST NA 00365702125100

    Patients

    Seq Age Sex Outcome Treatment
    1 Male