BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS

    MDR report key: 1771196 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01628
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS GREATER THAN 600 MG/DL ON THE COMPACT PLUS METER. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT. NUMERIC READING RANGE OF DEVICE IS 10 MG/DL TO 600 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NOVOLOG 7-30 - 2 YRS - 56 UNITS/DAY