BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1771265 · Received February 15, 2008

    Report

    Report Number
    1823260-2008-01580
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT RESULTS STORED IN THE MEMORY OF THE ADVANTAGE SYSTEM. REPORTER STATED IT STORED 401 MG/DL INSTEAD OF THE ACTUAL 160 MG/DL THE CUSTOMER OBTAINED. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT 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 11 YR NOVOLOG PEN JUNIOR - 9 YEARS - SLIDING SCALE| LANTUS - 9 YEARS - 17 UNITS NIGHTLY