BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1243222 · Received November 7, 2008

    Report

    Report Number
    1823260-2008-08258
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT THAT WAS IN THE HIGH 400'S (MG/DL) AND A BLOOD GLUCOSE RESULT IN THE 100'S (MG/DL) ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE RESULTS WERE OBTAINED WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550042

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HUMALOG 75/25| "ATENANOL"