BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1772025 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08183
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 31, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE ADVANTAGE SYSTEM WILL OCCASIONALLY DISPLAY ONLY ONE NUMBER IN THE MIDDLE OF THE METER SCREEN, WHICH IS OUTSIDE THE METER READING RANGE OF 10-600 MG/DL (DOES NOT KNOW WHAT THE NUMBER WAS). NO ACTIONS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR GLIPIZIDE - DOSE UNK 1/DAILY