BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR

    MDR report key: 2821036 · Received November 6, 2012

    Report

    Report Number
    1826988-2012-00585
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS NOT FEELING WELL SO SHE RAN A BLOOD GLUCOSE TEST ON HER CONTOUR METER AT APPROXIMATELY 11:00AM AND THE RESULT WAS 199MG/DL. THERE WAS NO MEDICATION ADJUSTMENT BUT ULTIMATELY SHE HAD A HYPOGLYCEMIC EPISODE AND MEMBERS OF HER HOUSEHOLD GAVE HER GLUCOSE TABLETS AND CRACKERS TO EAT. SHE RE-TESTED HERSELF ABOUT 11:30AM AND RECEIVED A READING OF 84MG/DL. THE TEST STRIPS WERE 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 2DC3F12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention