BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1122807 · Received August 14, 2008

    Report

    Report Number
    1823260-2008-06203
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE IN THE COAGUCHEK XS SYSTEM. REFERENCE MEDWATCH FOR SUSPECT DEVICE IN THE COAGUCHEK PST SYSTEM

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED A RESULT OF 3.1 INR ON THE COAGUCHEK PST SYSTEM AND 4.1 INR ON THE COAGUCHEK XS SYSTEM DURING DUPLICATE TESTING. RESULT OF 3.1 INR WAS REPORTED TO THE DOCTOR AND MEDICATIONS WERE NOT CHANGED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS-GJS GJS ROCHE DIAGNOSTICS 20157921

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR COUMADIN~YEARS| BABY ASPIRIN