BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8227689 · Received January 8, 2019

    Report

    Report Number
    1810909-2019-00013
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    December 11, 2018
    Report Date
    December 11, 2018
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    00301939697010
    PMA / PMN Number
    K121190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE IN THE INITIAL MDR WAS INADVERTENTLY CAPTURED AS JJX. THE CORRECT PRODUCT CODE FOR THIS REPORT IS NBW. HAS BEEN UPDATED WITH THE CORRECT PRODUCT CODE.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING ON HER CONTOUR NEXT METER THAT WAS 50 MG/DL HIGHER COMPARED TO THAT OBTAINED ON A DIFFERENT METER. THE SPECIFIC READINGS WERE NOT PROVIDED. DEPENDING ON THE ACTUAL READINGS, THE DIFFERENCE BETWEEN THEM COULD FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. A NEW METER KIT WAS SENT TO THE CUSTOMER. THE CUSTOMER LOST THE STRIPS AND THEREFORE, NO STRIP INFORMATION WAS AVAILABLE. AS THE CUSTOMER LOST THE TEST STRIPS, THEY ARE NOT EXPECTED TO BE RETURNED. 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
    19663 CONTOUR NEXT BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 9697 00301939697010

    Patients

    Seq Age Sex Outcome Treatment
    1