BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT TEST DRUM

    MDR report key: 1080598 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05674
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A 479MG/DL AND 229MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK COMPACT PLUS SYSTEM. THE CUSTOMER STATES HE OBTAINED AN ADDITIONAL COMPARISON WITH BLOOD GLUCOSE RESULTS 350MG/DL AND 180MG/DL ON THE ACCU-CHEK COMPACT PLUS SYSTEM. ON BOTH OCCASIONS, TEST RESULTS WERE OBTAINED WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON THE READINGS. 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 TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 20667441

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR METFORMIN - 3 MONTHS