BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 1770835 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09845
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 25, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE METER READ 42 MG/DL ON DISPLAY BEFORE DOSING THE STRIP WHILE USING THE COMPACT SYSTEM. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR LOVASTATIN - 20MG/DAY| LISINOPRIL - 10MG/DAY