BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 1770863 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09849
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 12, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE ACTIVE S SYSTEM HAD PRODUCED A SPARK. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR GLIPIZIDE 5MG ONCE DAILY - 13 YEARS| METFORMIN 500MG ONCE DAILY - 13 YEARS