BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8296140 · Received February 1, 2019

    Report

    Report Number
    1810909-2019-00057
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Date of Event
    January 4, 2019
    Report Date
    January 5, 2019
    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

    THE CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 279 AND 273 MG/DL AT 8:37 P.M. AND 8:40 P.M. RESPECTIVELY ON A CONTOUR NEXT ONE METER. AT 8:45 P.M., UPON REPEAT TESTING WITH A DIFFERENT METER, HE OBTAINED A READING OF 119 MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALLS IN "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES 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
    89616 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7308 8EPEG16A 10301937308502

    Patients

    Seq Age Sex Outcome Treatment
    1