BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 4122592 · Received September 26, 2014

    Report

    Report Number
    1826988-2014-00325
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K121190
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A CANADIAN CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 26.8MMOL/L ON THE CONTOUR NEXT METER. SHE FELT DIZZY AND NAUSEATED SO CALLED AN AMBULANCE. THE EMERGENCY PERSONNEL RETESTED HER ON A DIFFERENT METER AND THE READING WAS 8.6MMOL/L. THE CUSTOMER WAS TAKEN TO THE HOSPITAL, BUT COULD NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE INCIDENT. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. NEW TEST STRIPS AND METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601008 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 3JFEC32

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization