BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK XS SYSTEM

    MDR report key: 1772081 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09515
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 17, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    PMA / PMN Number
    K062925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS PATIENT TESTED 4.3 INR ON THE COAGUCHEK XS SYSTEM AND 1.8 INR ON A COMPARISON LAB. NO TREATMENT BASED ON DEVICE RESULTS. NO ADVERSE EVENTS REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK XS SYSTEM PROTHROMBIN TIME TEST STRIP ¿ GJS GJS ROCHE DIAGNOSTICS 20152731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COUMADIN - 5MG/DAY, ALTERNATE DAYS| COUMADIN - 2.5 MG/DAY, ALTERNATE DAYS