BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 709337 · Received May 3, 2006

    Report

    Report Number
    1823260-2006-02067
    Event Type
    Malfunction
    Date Received
    May 3, 2006
    Date of Event
    April 14, 2006
    Report Date
    April 15, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THERE ARE CRACKS AND STRANDING ON THE TEST STRIP VIAL. HE SAID KHE HAS BEEN GETTING HIGH RESULTS (210MG/DL) AND TAKING INSULIN, WHICH IS MAKING HIM TOO LOW DURING THE LAST TWO NIGHTS. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE NBW ROCHE DIAGNOSTICS NA 549079

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR