BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1200123 · Received October 15, 2008

    Report

    Report Number
    1823260-2008-07613
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 27, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK ADVANTAGE SYSTEM WITHIN 10 MINUTES: 550 MG/DL, 200 MG/DL AND 164 MG/DL. 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 550006

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR JANUVIA| INSULIN NPH (UNK TYPE) - 5-6 YEARS