BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 22384724 · Received July 2, 2025

    Report

    Report Number
    1810909-2025-00101
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    May 28, 2025
    Report Date
    July 2, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003977404
    PMA / PMN Number
    K210687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE SUSPECTED DEVICE FOR EVALUATION. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE IN-HOUSE CONTOUR® NEXT ONE METER WITH SERIAL (B)(6) AND IN-HOUSE CONTOUR® NEXT TEST STRIPS FROM LOT # 4EPEG31A, USING BLOOD SPIKED WITH GLUCOSE AT 3.8 MMOL/L, AS DETERMINED BY YSI INSTRUMENT IN FIVE REPLICATES. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS. THE INITIAL REPORTER (E1) CONTACT DETAILS WERE NOT PROVIDED. UNKNOWN WAS CAPTURED IN SECTION A1, AND NO INFORMATION WAS CAPTURED IN SECTION A4, AS THE PATIENT'S WEIGHT WAS NOT PROVIDED. THE CONTOUR® NEXT TEST STRIPS WITH SKU # 9774 AND LOT # 4EPEG31A HAS THE 510K# OF K210687 AND (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL (HCP) FROM CHINA REPORTED THAT WHILE PERFORMING BLOOD GLUCOSE TESTS ON ONE OF THEIR PATIENTS WITH THE CONTOUR® NEXT ONE METER, THEY OBTAINED BLOOD GLUCOSE READINGS OF 0.7 MMOL/L WITH ONE VIAL OF TEST STRIPS AND 8.0 MMOL/L WITH ANOTHER VIAL OF TEST STRIPS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE HCP DISCARDED THE TEST STRIPS ASSOCIATED WITH THE EVENT, THEREFORE, THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142142 CONTOUR® NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 9774 4EPEG31A 05016003977404

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female