BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1203665 · Received October 16, 2008

    Report

    Report Number
    1823260-2008-07658
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CALLER STATES THE PT TESTED 1.7 INR ON THE COAGUCHEK S SYSTEM AND 2.2 INR ON THE COAGUCHEK XS SYSTEM DURING DUPLICATE TESTING. NO ACTION TAKEN ON DEVICE RESULT. 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 20164731

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR COUMADIN - 42.5 MG/WK| GLUCOPHAGE