BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2881056 · Received December 20, 2012

    Report

    Report Number
    1826988-2012-00663
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD RECEIVED A BLOOD RESULT ON THE CONTOUR METER OF APPROXIMATELY 410MG/DL. HE RE-TESTED HIS BLOOD ON A DIFFERENT METER AND THE READING WAS 120MG/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 TEST STRIPS WERE RETURNED FOR EVALUATION. 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 1KC3F14

    Patients

    Seq Age Sex Outcome Treatment
    1