BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1760856 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06056
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE ADVANTAGE SYSTEM GENERATED A RESULT OF 0 MG/DL WHICH IS OUTSIDE THE READING RANGE OF 10-600 MG/DL AND WHEN GLUCOSE IS BELOW 10 MG/DL IS DISPLAYED AS LO. REPORTER STATED NOT BEING ABLE TO LOCATE THE READING IN THE SYSTEM MEMORY. NO ACTIONS WERE TAKEN OR TREATMENT REPORTED. 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 69 YR TWICE DAILY| HUMALOG INSULIN - 2YRS - 6 UNITS SLIDING SCALE| HUMULIN N - 10YRS - 25UNITS ONCE DAILY