BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2862672 · Received December 10, 2012

    Report

    Report Number
    1826988-2012-00637
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER AND ADDRESS WERE NOT PROVIDED.

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 120MG/DL FROM HER CONTOUR AND A READING OF 276MG/DL FROM THE DOCTOR'S 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 TEST STRIPS ARE TO BE RETURNED FOR EVALUATION.REPLACEMENT TEST STRIPS AND A NEW 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 2DC3B02

    Patients

    Seq Age Sex Outcome Treatment
    1