BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2494266 · Received March 16, 2012

    Report

    Report Number
    1826988-2012-00114
    Event Type
    Malfunction
    Date Received
    March 16, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 18, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LFR
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 49 MG/DL FROM HER CONTOUR METER AND A READING OF 159 MG/DL FROM ANOTHER METER.THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT.NO ADVERSE EVENT WAS ALLEGED.THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION.REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS BLOOD GLUCOSE TEST STRIPS LFR BAYER HEALTHCARE LLC 7080G 1CC3C03

    Patients

    Seq Age Sex Outcome Treatment
    1