BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS BLUE

    MDR report key: 25149685 · Received May 12, 2026

    Report

    Report Number
    1810909-2026-00025
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003773617
    PMA / PMN Number
    K241787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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. THE CONTOUR® PLUS BLUE METER DOES NOT HAVE AN EXPIRATION DATE. THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (EXPIRATION DATE). THE WARRANTY PERIOD OF THE METER IS 5 YEARS FROM THE DATE OF THE ORIGINAL PURCHASE. THE CONTOUR® PLUS BLUE METER WITH SKU # 7736E AND SERIAL # (B)(6) HAS 510K # OF K241787 AND UDI (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER FROM UNITED KINGDOM CONTACTED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® PLUS BLUE METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE CUSTOMER¿S BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN 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
    242469 CONTOUR® PLUS BLUE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7736E DP04V084P 05016003773617

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male