BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1770597 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09321
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    September 9, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K930979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER'S ADVANTAGE SYSTEM GENERATED A BLOOD GLUCOSE RESULT IN THE 650'S MG/DL WHICH IS OUTSIDE THE READING RANGE OF 10-600 MG/DL FOR THE SYSTEM. NO ACTIONS WERE REPORTEDLY 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 62 YR AVANDIA - 8 MG ONCE DAILY| GLUCOTROL - 10 MG TWICE DAILY| LOTREL -