BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1771205 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01648
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 3, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER WAS UNABLE TO OBTAIN BLOOD GLUCOSE RESULT ON THE ADVANTAGE SYSTEM WHEN INSERTING A TEST STRIP BECAUSE METER WAS GENERATING ERROR MESSAGES AND WOULD HAVE NO POWER. REPORTER STATED THE CUSTOMER WAS INCOHERENT WHEN THE ATTEMPT TO TEST WAS UNSUCCESSFUL AND UNABLE TO SELF TREAT. REPORTER INDICATED GIVING THE CUSTOMER FOOD HOWEVER NO OTHER ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT WAS RECEIVED BY THE CUSTOMER. 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 30 YR UNK, DOSE AND FREQUENCY UNK