BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 22151847 · Received June 5, 2025

    Report

    Report Number
    1810909-2025-00087
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    May 13, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003730603
    PMA / PMN Number
    K210687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. THE CONTOUR® NEXT TEST STRIPS WITH SKU#: 7306A AND LOT#: 4DPEF01A HAS THE 510K# OF K210687 AND UDI (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® NEXT ONE METER (SERIAL # (B)(6)) FOR EVALUATION. NO TEST STRIPS WERE RETURNED. AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED METER AND IN-HOUSE CONTOUR® NEXT TEST STRIPS (LOT # 4DPEF01A) USING BLOOD SPIKED WITH GLUCOSE AT 131 MG/DL AND 68 MG/DL, AS DETERMINED BY YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN FIT-FOR-USE LIMITS.

    Description of Event or Problem · 0

    A CUSTOMER FROM (B)(6) REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 19 MG/DL AT 9:06 A.M. AND 128 MG/DL AT 9:07 A.M. WITH THE CONTOUR® NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAD ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936604 CONTOUR® NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7306A 4DPEF01A 05016003730603

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female