BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 21425931 · Received February 20, 2025

    Report

    Report Number
    1810909-2025-00027
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 28, 2025
    Report Date
    February 20, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K160430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DISCONNECTED THE CALL. DESPITE THREE FOLLOW-UP ATTEMPTS, THE CUSTOMER COULD NOT BE REACHED. THEREFORE, THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® PLUS METER WITH SERIAL#: (B)(6) AND NO MANUFACTURING ANOMALIES WERE FOUND. 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 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. SKU#: 7703 OF THE CONTOUR® PLUS METER IS ONLY AVAILABLE IN MEXICO; THEREFORE, THE UDI# IS NOT APPLICABLE. CONTOUR® PLUS METER IS SIMILAR TO THE CONTOUR® NEXT METER AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K)#: K160430 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 REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® PLUS METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER DISCONTINUED THE CALL. THEREFORE, THE DEVICE COULD NOT BE REQUESTED BACK FOR EVALUATION AND A REPLACEMENT METER COULD NOT BE OFFERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394678 CONTOUR® PLUS BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7703 DP08T024P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male