BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2800211 · Received October 22, 2012

    Report

    Report Number
    1826988-2012-00557
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 212MG/DL FROM HER LAB TEST AND AN APPROXIMATE READING OF 71MG/DL FROM HER CONTOUR 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. CUSTOMER HAS NO STRIPS LEFT SO NO PRODUCT WILL BE RETURNED. REPLACEMENT TEST STRIPS AND METER WERE SENT TO THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 1LC3B10

    Patients

    Seq Age Sex Outcome Treatment
    1