BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8232225 · Received January 9, 2019

    Report

    Report Number
    1810909-2019-00022
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 12, 2018
    Report Date
    December 12, 2018
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    10301937278706
    PMA / PMN Number
    K160682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A BLOOD GLUCOSE READING OF 45 MG/DL ON A CONTOUR NEXT ONE METER. UPON REPEAT TESTING WITHIN 5 MINUTES ON A DIFFERENT METER, A READING OF 245 MG/DL WAS OBTAINED. THE CUSTOMER HAD NO SYMPTOMS OF HYPOGLYCEMIA OR HYPERGLYCEMIA. THE DIFFERENCE BETWEEN THE READINGS FALLS IN "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22931 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7278 7LPEC426 10301937278706

    Patients

    Seq Age Sex Outcome Treatment
    1