BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1083734 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05743
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2 (LOT NUMBER 20163731, EXPIRATION DATE 06/30/2009). REFERENCE MEDWATCH REPORT WITH A1 PATIENT FOR THE SUSPECT DEVICE USED IN SYSTEM 1.

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED 4.4 INR ON THE COAGUCHEK XS SYSTEM 1 AND 4.3 INR ON COAGUCHEK XS SYSTEM 2, WHILE A COMPARISON LAB RETURNED AS 3.07 INR. NO TREATMENT INFORMATION PROVIDED. 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 20163731

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR WARFARIN| TOPROL