BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 586261 · Received March 21, 2005

    Report

    Report Number
    1823260-2005-00470
    Event Type
    Malfunction
    Date Received
    March 21, 2005
    Date of Event
    February 22, 2005
    Report Date
    February 22, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    WHEN REVIEWING DEVICE RESULTS, CUSTOMER ALLEGED MEMORY DISCREPANCIES FOR TWO DEVICES. ADDITIONAL RESULTS WERE NOTED IN THE LOGBOOK AND DIARY. BOTH DEVICES DISPLAY DUPLICATE RESULTS FOUR DIFFERENT DAYS. DEVICE RESULTS 132, 133, 155, AND 141 MG/DL WERE NOT FOUND IN ONE DEVICE. NO ADDITIONAL TESTS WERE DONE. NO CONTROLS WERE USED. A REQUEST FOR RETURN PRODUCT WAS MADE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other