BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 23016616 · Received September 10, 2025

    Report

    Report Number
    1810909-2025-00137
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 19, 2025
    Report Date
    September 10, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K191286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. GUDID INFORMATION DOES NOT EXISTS, AS THE CUSTOMER DID NOT PROVIDE THE PRODUCT INFORMATION. CONTOUR® PLUS METER IS SIMILAR TO THE CONTOUR® NEXT METER AVAILABLE IN THE US MARKET. THEREFORE, DEVICE PRODUCT CODE AS NBW HAS BEEN CAPTURED IN SECTION D2B AND 510K # HAS BEEN CAPTURED AS K191286 IN SECTION G4.

    Description of Event or Problem · 0

    THE CUSTOMER FROM UNITED KINGDOM REPORTED THAT HE BOUGHT THE CONTOUR® PLUS METER FROM EBAY AND THE METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MG/DL INSTEAD OF MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048448 CONTOUR® PLUS BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male