BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 18247514 · Received December 1, 2023

    Report

    Report Number
    1810909-2023-00256
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 16, 2023
    Report Date
    November 16, 2023
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K160682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTION A (A1 - PATIENT INITIALS, A2 - AGE, A3 - GENDER AND A4 - WEIGHT) AS THE PATIENT DETAILS WERE NOT PROVIDED. THE CUSTOMER DID NOT PROVIDE THE PRODUCT INFORMATION. THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (MODEL #, LOT # AND EXPIRATION DATE), AND DEVICE MANUFACTURE DATE (H4) COULD NOT BE DETERMINED. THE CUSTOMER DID NOT PROVIDE THE METER BRAND NAME ASSOCIATED WITH THE EVENT. SINCE THE CUSTOMER INFORMED ASCENSIA ABOUT THE EVENT WITH REVIEW RATING ON THE CONTOUR DIABETES APP, IT IS ASSUMED THAT THE METER CONNECTED WITH THE CONTOUR DIABETES APP WAS EITHER CONTOUR NEXT ONE METER OR CONTOUR NEXT GEN METER. SINCE THE CONTOUR NEXT ONE METER WAS LAUNCHED PRIOR TO THE CONTOUR NEXT GEN METER IN THE US, THE 510(K) # IN SECTION G4 HAS BEEN CAPTURED K160682, WHICH IS ASSOCIATED WITH THE CONTOUR NEXT ONE METER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY OBTAINED BLOOD GLUCOSE READINGS OF 504 MG/DL AND 131 MG/DL WITH THE ASCENSIA METER. NO PRODUCT DETAILS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539227 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown