BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8232223 · Received January 9, 2019

    Report

    Report Number
    1810909-2019-00025
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 10, 2018
    Report Date
    December 12, 2018
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    10301937311502
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE OBTAINED A BLOOD GLUCOSE READING OF 569 MG/DL AT 5:05 A.M. ON A CONTOUR NEXT LINK METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPERGLYCEMIA. UPON REPEAT TESTING AT THE SAME TIME, SHE OBTAINED A READING OF 171 MG/DL ON A CONTOUR NEXT ONE METER. THE CUSTOMER ALSO PERFORMED REPEAT TESTING WITH HER CONTOUR METER AND OBTAINED A LOWER READING COMPARED TO THE CONTOUR NEXT LINK METER. SPECIFIC READING OBTAINED ON THE CONTOUR METER WAS NOT PROVIDED. THE DIFFERENCE BETWEEN READINGS FALLS IN "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT FOR EVALUATION. REPLACEMENT METERS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22929 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7311 8DPEF02A 10301937311502

    Patients

    Seq Age Sex Outcome Treatment
    1