BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1022324 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02803
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT 2: MALE, MEDICATION: COUMADIN, ORAL CHEMOTHERAPY. MEDICAL HISTORY: BLOOD CLOTS, DEEP VEIN THROMBOSIS. PATIENT 3: NO INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CALLER STATES DURING A STUDY, THE FOLLOWING COAGUCHEK XS/LABORATORY RESULTS WERE OBTAINED: 2.6 INR/1.98 INR. 2.9 INR/1.48 INR. 2.6 INR/1.81 INR. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.

    Additional Manufacturer Narrative · 2

    PATIENT 3: NO INFORMATION PROVIDED.

    Description of Event or Problem · 2

    CALLER STATES DURING A CORRELATION STUDY THE FOLLOWING COAGUCHEK XS/LABORATORY RESULTS WERE OBTAINED: 2.6 IN/1.98 INR. 2.9 IN/1.48 INR. 2.6 INR/1.81 INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIPS -GJS GJS ROCHE DIAGNOSTICS 20158631

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR COUMADIN 2MG/3MG/ALTERNATING
    2 ORAL CHEMOTHERAPY| PATIENT 2: MEDICATION: COUMADIN