BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083326 · Received July 25, 2008

    Report

    Report Number
    1823260-2008-05786
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A "HI" (GREATER THAN 600MG/DL) ON THE ACCU-CHEK ADVANTAGE SYSTEM IN COMPARISON TO THE PROFESSIONAL METER RESULT OF 156MG/DL. THE RESULTS WERE OBTAINED WITHIN A TEN MINUTE TIMEFRAME. THE CUSTOMER STATES HE FELT SHAKY DUE TO THE TEST RESULTS AND THAT HE HAD NO SYMPTOMS. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. 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 550673

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR METFORMIN - 3 MONTHS| GLIPIZIDE - 4 MONTHS