BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK COMFORT CURVE TEST STRIPS

    MDR report key: 1020189 · Received March 26, 2008

    Report

    Report Number
    1823260-2008-02754
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    10362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    DIETICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A 101 MG/DL AND 59 MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE RESULTS WERE OBTAINED WITHIN A 10 MIN TIMEFRAME. THE CUSTOMER EXPERIENCED NERVOUSNESS AND SHAKINESS. HE TREATED HIMSELF WITH OJ. THE RESULTS OF THE TREATMENT WAS UNDISCLOSED. 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-CHECK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK