BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1060120 · Received June 10, 2008

    Report

    Report Number
    1823260-2008-04614
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER WAS TESTED WITH THE BLOOD GLUCOSE RESULT OF 411 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM IN COMPARISON TO THE BLOOD GLUCOSE RESULT OF 190 MG/DL ON THE PROFESSIONAL METER. THE RESULTS WERE OBTAINED WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN. 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 549908

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LANTUS UNK DOSE/FREQ| UNK MED SLIDING SCALE - UNK PARAMETERS