BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040983 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03861
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 8, 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 REPORTER STATES THAT HE OBTAINED THE BLOOD GLUCOSE COMPARISON OF 46 MG/DL AND 219 MG/DL ON THE ACCU-CHEK ADVANTAGE SYS. THE REPORTER OBTAINED AN ADD'L COMPARISON WITH THE BLOOD GLUCOSE RESULTS OF 46 MG/DL AND 156 MG/DL ON THE ACCU-CHEK ADVANTAGE SYS. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN. NO ADVERSE EVENT REPORTED. NEW SYS 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 549643

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR