BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 887865 · Received May 7, 2007

    Report

    Report Number
    1823260-2007-03835
    Event Type
    Malfunction
    Date Received
    May 7, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 7, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE ADVANTAGE SYSTEM GENERATED A RESULT OF 800-900 MG/DL WHICH IS OUTSIDE THE ACCEPTABLE RANGE OF 10-600 MG/DL. THE LOCATION OF THE ALLEGED INCIDENT WAS NOT PROVIDED. NO ACTIONS WERE TAKEN OR TREATMENT 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 NA YR GLIPIZIDE - 20 MG ONCE DAILY| HYDROCHOLORTHIAZIDE - 25 MG ONCE DAILY| SIMVASTATIN - 20 MG ONCE DAILY| FOSINOPRIL - 20 MG ONCE DAILY| ATENOLOL - 25 MG ONCE DAILY| AROLLAZONE - 8 MG ONCE DAILY| NOVOLIN - SLIDING SCALE| NPH - 18UN ONCE DAILY| ASPIRIN - 81 MG ONCE DAILY