BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS BLUE

    MDR report key: 21596236 · Received March 13, 2025

    Report

    Report Number
    1810909-2025-00048
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 21, 2025
    Report Date
    May 22, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003773600
    PMA / PMN Number
    K231679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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® 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 # 7736 AND SERIAL # (B)(6) HAS THE 510K # K231679 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    DESPITE THE FOLLOW-UP ATTEMPTS, THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® PLUS BLUE METER WITH SERIAL # (B)(6), AND NO MANUFACTURING ANOMALIES WERE FOUND.

    Description of Event or Problem · 0

    THE CUSTOMER FROM UNITED KINGDOM REPORTED THAT HER BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® PLUS BLUE METER. 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
    1700896 CONTOUR® PLUS BLUE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7736 DP07S179P 05016003773600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female