BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1032683 · Received April 22, 2008

    Report

    Report Number
    1823260-2008-03417
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK SYSTEM 2.

    Description of Event or Problem · 1

    THE REPORTER STATES THAT HE OBTAINED THE BLOOD GLUCOSE RESULTS OF 123 MG/DL AND 116 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM 1 IN COMPARISON TO THE BLOOD GLUCOSE RESULT OF 310 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM 2. THE RESULTS WERE OBTAINED WITHIN A 10 MIN 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 550518

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR AMLODIPINE| LISINOPRIL| ACTOPLUS MET/METFORMIN| ATENOLOL