BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022339 · Received March 27, 2008

    Report

    Report Number
    1823260-2008-02821
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT HE OBTAINED A 120MG/DL AND 64MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK ADVANTAGE SYS. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. THE RPTR FELT SWEATY AND JITTERY. HE TREATED HIMSELF BY DRINKING OJ. HE FELT BETTER 5 MINUTES AFTER TREATMENT. 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 549949

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR HUMALOG 1 UNIT/50 CARBS - 10 YEARS| LANTUS 35 UNITS/DAY - 8-9 YEARS