BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 22965571 · Received September 4, 2025

    Report

    Report Number
    1810909-2025-00128
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 5, 2025
    Report Date
    January 15, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    UDI-DI
    05016003734007
    PMA / PMN Number
    K151742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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 SECTIONS A2 AND A4 AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE CONTOUR® NEXT CONTROL SOLUTION WITH SKU # 7340 AND LOT # 5BV2D56 HAS 510K # OF K151742 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 OR CONTROL SOLUTION WERE RETURNED. SINCE THE CONTOUR® NEXT TEST STRIPS ASSOCIATED WITH THE EVENT EXPIRED, AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED METER, IN-HOUSE CONTOUR® NEXT TEST STRIPS (LOT# 4CHEG07A) AND IN-HOUSE CONTOUR® NEXT CONTROL SOLUTION (LOT # 5BV2D56) IN FIVE REPLICATES. ALL TESTS RECOVERED WITHIN THE EXPECTED CONTROL RANGE OF 112 MG/DL TO 140 MG/DL. THE CONTROL RESULTS OBTAINED WITH THE IN-HOUSE TESTING WERE PROPERLY MARKED AS CONTROL TESTS IN THE METER.

    Description of Event or Problem · 0

    THE CUSTOMER FROM GREECE REPORTED THAT HE RAN CONTROL TESTS WITH THE CONTOUR® NEXT ONE METER AND OBTAINED READINGS OF 152 MG/DL, 143 MG/DL AND 131 MG/DL. THE METER DID NOT AUTOMATICALLY MARK THE READING OF 143 MG/DL AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS 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
    1675787 CONTOUR® NEXT QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC. 7340 5BV2D56 05016003734007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male