BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1772017 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08147
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 30, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER OBTAINED RESULTS OF 600 MG/DL AND 120 MG/DL ON ACCU-CHEK ADVANTAGE SYSTEM. CUSTOMER REPORTS ADDITIONAL COMPARISON WITH RESULTS OF "HI" (GREATER THAN 600 MG/DL) AND 97 MG/DL ON ACCU-CHEK ADVANTAGE SYSTEM. ON BOTH OCCASIONS, TEST RESULTS WERE OBTAINED WITH 10 MINUTES. NO ACTION WAS TAKEN BASED ON THE READINGS. 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 549610

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR OXYBUTYNIN - 5 MG/DAY - 4 YEARS| FLUOXETINE - 40 MG/DAY - 1 YEAR| EVISTA - 60 MG/DAY - 4-5 YEARS| CRESTOR - 10 MG/DAY - 3/4 YEARS| BYETTA - 10 MCG/DAY - ONE AND A HALF YEARS| SINGULAIR - 10 MG/DAY - 5/6 YEARS| METFORMIN - 2000 MG/DAY - 4/5 YEARS| LISINOPRIL - 10 MG/DAY - 2 YEARS OR MORE| MELOXICAM - 15 MG/DAY - 1 YEAR| OMEPRAZOLE - 20 MG/DAY - 1 YEAR