BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8244839 · Received January 14, 2019

    Report

    Report Number
    1810909-2019-00035
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    December 21, 2018
    Report Date
    December 21, 2018
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    10301937308502
    PMA / PMN Number
    K160682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 12:22 A.M., THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 256 MG/DL ON A CONTOUR NEXT ONE METER. AT 12: 24 A.M., UPON REPEAT TESTING WITH THE CONTOUR NEXT LINK METER, A READING OF 101 MG/DL WAS OBTAINED. THE CUSTOMER HAD SYMPTOMS OF HYPERGLYCEMIA SUCH AS SHAKINESS, FEELING HOT, SWEATING, AND FEELING THIRSTY. THE DIFFERENCE BETWEEN READINGS FALLS IN "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE STRIPS ARE NOT EXPECTED TO BE RETURNED AS THE CUSTOMER USED ALL THE STRIPS. REPLACEMENT METERS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37137 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7308 8GPEB08C 10301937308502

    Patients

    Seq Age Sex Outcome Treatment
    1