BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 12851765 · Received November 22, 2021

    Report

    Report Number
    1810909-2021-00397
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    December 29, 2020
    Report Date
    December 29, 2020
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K160682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE CUSTOMER DID NOT PROVIDE THE PRODUCT DETAILS. THEREFORE, NO INFORMATION WAS CAPTURED (MODEL #, LOT # AND EXPIRATION DATE), AND THE DEVICE MANUFACTURE DATE) COULD NOT BE DETERMINED. THE CONTOUR NEXT (CONNECTED) METER IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE CONTOUR NEXT ONE METER WITH THE PRODUCT CODE NBW AND 510 (K) # K160682, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 0

    THE CUSTOMER FROM (B)(6) REPORTED THAT WITHIN 10 MINUTES, SHE OBTAINED BLOOD GLUCOSE READINGS OF 2.4 MMOL/L, 2.8 MMOL/L AND 7.4 MMOL/L WITH THE CONTOUR NEXT (CONNECTED) METER. 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
    1749369 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female