BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT LINK 2.4

    MDR report key: 8232224 · Received January 9, 2019

    Report

    Report Number
    1810909-2019-00024
    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
    00301936260019
    PMA / PMN Number
    P150001
    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 A BLOOD GLUCOSE READING OF 565 MG/DL AT 11:37 A.M. ON A CONTOUR NEXT LINK 2.4 METER. UPON REPEAT TESTING WITH A DIFFERENT METER, A READING OF 245 MG/DL WAS OBTAINED. THE CUSTOMER TOOK SEVEN UNITS OF INSULIN BASED ON THE READING OF 565 MG/DL. THE CUSTOMER HAD NO SYMPTOMS OF 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. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22930 CONTOUR NEXT LINK 2.4 BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 6260 00301936260019

    Patients

    Seq Age Sex Outcome Treatment
    1