BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8235556 · Received January 10, 2019

    Report

    Report Number
    1810909-2019-00026
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 12, 2018
    Report Date
    December 12, 2018
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(6) CUSTOMER REPORTED THAT SHE OBTAINED A READING OF 180 MG/DL ON A CONTOUR XT METER. A FEW MINUTES LATER, A REPEAT TESTING WAS PERFORMED ON A CONTOUR NEXT METER AND A READING OF 55 MG/DL WAS OBTAINED. THE CUSTOMER WAS FEELING WEAK, HAD POOR VISIBILITY AND WENT TO BED. DEPENDING ON THE CORRECT READING, THE DIFFERENCE BETWEEN THE READINGS FALLS IN "C" OR "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. 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
    29465 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 8BPE16A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR