BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT PLUS (GT)

    MDR report key: 1230906 · Received November 6, 2008

    Report

    Report Number
    1823260-2008-08212
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K081389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS METER DISPLAY "ERR" WHILE USING THE COMPACT PLUS GT SYSTEM. ERROR MESSAGE IS OUTSIDE OF THE DEVICE'S SPECIFICATIONS. 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 PLUS (GT) BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR METFORMIN - 9 YEARS| HUMALOG 75/25 - 1 YEAR