BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1220079 · Received October 31, 2008

    Report

    Report Number
    1823260-2008-08088
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 26, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED OBTAINED BLOOD GLUCOSE RESULTS OF 403 MG/DL AND 136 MG/DL WHEN TESTING WAS PERFORMED BACK-TO-BACK ON THE COMPLETE SYSTEM. NO SYMPTOMS, ACTION, OR TREATMENT BASED ON THE RESULTS WAS REPORTED. NO SERIOUS ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 550032

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR METFORMIN 1000MG/2/DAY - 8 YEARS| PRANDIN 2MG/2/DAY - 8 YEARS| ACTOS 45MG/DAY - 2 YEARS