BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1052030 · Received May 21, 2008

    Report

    Report Number
    1823260-2008-04178
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    May 11, 2008
    Report Date
    May 21, 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

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 80 MG/DL AND A RESULT OF 32 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER SELF TREATED BASED ON LOW BLOOD GLUCOSE SYMPTOMS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 550509

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR NOVOLOG 30 UNITS WITH MEALS| LANTUS 70 UNITS PER DAY - 2 YEARS