BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU- CHEK COMFORT CURVE

    MDR report key: 624276 · Received August 2, 2005

    Report

    Report Number
    1823260-2005-02238
    Event Type
    Malfunction
    Date Received
    August 2, 2005
    Date of Event
    July 14, 2005
    Report Date
    July 14, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED SUSPECT DEVICE = "HHI" VERSUS LAB = 360 MG/DL PERFORMED WITHIN 30 MINUTES OF EATH OTHER. BOTH LEVELS OF GLUCOSE CONTROLS PASSED. NO TREATMENT WAS ADMINISTERED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU- CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS MA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other