BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3040401 · Received April 8, 2013

    Report

    Report Number
    1826988-2013-00137
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RAN BLOOD GLUCOSE TESTS ON HER CONTOUR LINK METER AND RECEIVED READINGS OF 296 AND 365MG/DL. SHE ALSO TESTED ON A DIFFERENT METER AND THE READING WAS 116MG/DL. 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 RETURNED THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143706 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7098B 2GC3D09

    Patients

    Seq Age Sex Outcome Treatment
    1