BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 1781008 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06550
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 14, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K031755
    Removal / Correction Number
    Z-0976-05
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED OBTAINING UNDOSED RESULTS RANGING BETWEEN 200-250MG/DL ON THE COMPACT SYSTEM. NO ADVERSE EVENT REPORTED. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    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 57 YR LISINOPRIL 25MG/DAY| VYTORIN 10-80MG 1 TAB/DAY