BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COAGUCHEK SYSTEM

    MDR report key: 1780556 · Received September 19, 2007

    Report

    Report Number
    1823260-2007-08198
    Event Type
    Malfunction
    Date Received
    September 19, 2007
    Date of Event
    August 23, 2007
    Report Date
    September 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES SHE SAW A SPARK IN THE BATTERY COMPARTMENT OF THE COAGUCHEK PST. STATES NO BLACK MARKS OR MELTING IN THE BATTERY COMPARTMENT AND NOT HOT TO TOUCH. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAGUCHEK SYSTEM PROTHROMBIN TIME MONITOR - GJS GJS ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA MEDICATIONS UNKNOWN