BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1771183 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01248
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A RESULT OF 888 MG/DL ON THE ADVANTAGE SYSTEM WHICH IS OUTSIDE THE NUMERIC READING RANGE OF THE 10-600 MG/DL OF THE DEVICE. REPORTER STATED SHE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING, SO SHE SELF TREATED WITH FOOD AND MILK. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 81 YR ACTOS - TIME UNK - 15MG TWICE DAILY