BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 3813282 · Received May 15, 2014

    Report

    Report Number
    1826988-2014-00180
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAS BEEN ADJUSTING INSULIN DOSAGES, THROUGH HER INSULIN PUMP, ACCORDING TO HER BLOOD GLUCOSE READINGS ON THE CONTOUR NEXT LINK METER. ONE EVENING HER BLOOD GLUCOSE READING DROPPED TO 33MG/DL AND SHE HAD HYPOGLYCEMIC SYMPTOMS. MOST RECENTLY, SHE PASSED OUT WHEN HER BLOOD GLUCOSE READINGS WERE STARTING TO CLIMB AGAIN. DETAILS WERE NOT PROVIDED, SO IT IS UNKNOWN IF SHE RECEIVED MEDICAL TREATMENT. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289292 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7311 3GFEF02

    Patients

    Seq Age Sex Outcome Treatment
    1