BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770888 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09819
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 22, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF: 73MG/DL TO 154MG/DL; 64MG/DL TO 344MG/DL; 344MG/DL TO 64MG/DL; 344MG/DL TO 54MG/DL. NO QUALITY CONTROLS WERE RUN DURING THE CALL. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    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 549909

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR ZOCOR 40MG/DAY - 3 YRS| ATENOLOL 20MG/DAY - 9 MONTHS| GLYBURIDE 1/2 PIL/DAY - 2 MONTHS| METFORMIN 500MG/DAY - 3 YRS| GLUCERNA| ASPIRIN DAILY - 1 MONTH| SINGULAIR 10MG/DAY - 3 YRS