BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 6238103 · Received January 10, 2017

    Report

    Report Number
    1826988-2016-00483
    Event Type
    Injury
    Date Received
    January 10, 2017
    Date of Event
    November 19, 2016
    Report Date
    December 13, 2016
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED HER HUSBAND HAD BEEN GETTING BLOOD GLUCOSE READINGS OF 100-142 MG/DL ON THE CONTOUR NEXT LINK, BUT THEN WAS FOUND UNRESPONSIVE AFTER HE WENT TO SLEEP. HE WAS TAKEN TO THE HOSPITAL WHERE HIS BLOOD GLUCOSE WAS TESTED AT 34 MG/DL. HE WAS GIVEN TUBES OF GLUCOSE. THE PATIENT WAS RELEASED FROM THE ER FOUR HOURS LATER WITH A BLOOD GLUCOSE OF 183 MG/DL. CUSTOMER MIXED STRIPS FROM VARIOUS BOTTLES. PRODUCT WAS NOT EXPECTED TO BE RETURNED. NEW METER AND STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21604 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7308 5HFEG14

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R