BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT ONE

    MDR report key: 18345095 · Received December 18, 2023

    Report

    Report Number
    1810909-2023-00271
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    December 1, 2023
    Report Date
    April 18, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K160682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 SECTION A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. THE DEVICE IDENTIFIER # IN SECTION D4 WAS LEFT BLANK AS IT COULD NOT BE DETERMINED BASED ON THE AVAILABLE MODEL #.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR NEXT ONE METER WITH SERIAL # 7870520 AND NO MANUFACTURING ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: SECTIONS D1 (BRAND NAME) AND D4 (MODEL #, CATALOG # AND LOT #) HAVE BEEN UPDATED. THE CONTOUR® NEXT ONE 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 # 7826 OF THE CONTOUR® NEXT ONE METER IS ONLY AVAILABLE IN CANADA; THEREFORE, NO GUDID INFORMATION EXISTS AND THE UDI NUMBER IS NOT APPLICABLE.

    Description of Event or Problem · 0

    AN ADVOCATE FROM CANADA CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEIR BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68171 CONTOUR® NEXT ONE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7826 DM02S342P

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male