BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1780171 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08310
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    September 7, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE PATIENT TESTED >8.0 INR ON THE COAGUCHEK XS SYSTEM AND 4.1 INR ON A COMPARISON LAB. COUMADIN WAS HELD FOR 2 DAYS BASED 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 STRIP - GJS GJS ROCHE DIAGNOSTICS 20155331

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR COUMADIN - 5MG/MON, 2.5MG/REST