BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 23933646 · Received December 31, 2025

    Report

    Report Number
    1810909-2025-00166
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 4, 2025
    Report Date
    February 23, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K191286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE CONTOUR® PLUS TEST STRIPS FROM LOT # 5BQHH05A. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® PLUS TEST STRIPS FOR LOT # 5BQHH05A AND NO MANUFACTURING ANOMALIES WERE FOUND. AS PER THE HISTORICAL REVIEW OF THE EVENT FOR THE SIMILAR ISSUES, MODIFICATIONS WERE MADE TO THE CARTON DIMENSIONS TO HELP PREVENT VIAL CAPS FROM OPENING AFTER PACKAGING.

    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. SKU # 7706 OF THE CONTOUR® PLUS TEST STRIPS IS ONLY AVAILABLE IN MEXICO; THEREFORE, THE UDI # IS NOT APPLICABLE. THE CONTOUR® PLUS TEST STRIPS USED WITH THE CONTOUR® PLUS METER IS SIMILAR TO THE CONTOUR® NEXT TEST STRIPS USED WITH THE CONTOUR® NEXT METER AVAILABLE IN THE US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K191286 ASSOCIATED WITH THE CONTOUR® NEXT METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER FROM MEXICO REPORTED THAT HE OPENED A BOX OF CONTOUR® PLUS TEST STRIPS AND FOUND THAT THE BOTTLE WAS ALREADY OPEN. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563972 CONTOUR® PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7706 5BQHH05A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male