BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 21092775 · Received January 7, 2025

    Report

    Report Number
    1810909-2025-00009
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 9, 2024
    Report Date
    January 14, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K223293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 METER WITH SERIAL # (B)(6), AND NO MANUFACTURING ANOMALIES WERE FOUND. THE METER KIT LOT # HAS BEEN UPDATED IN SECTION D4.

    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® NEXT 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. MODEL # 9651E OF THE CONTOUR® NEXT METER IS ONLY AVAILABLE IN SWEDEN; THEREFORE, THE UDI # IS NOT APPLICABLE. CONTOUR® NEXT METER IS SIMILAR TO THE CONTOUR® NEXT GEN METER AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K223293 ASSOCIATED WITH THE CONTOUR® NEXT GEN METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE KIT # ASSOCIATED WITH THE METER IS NOT AVAILABLE. IF THE INFORMATION IS AVAILABLE AT THE LATER DATE, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER FROM SWEDEN REPORTED INACCURACIES IN THE 7-DAY, 30-DAY AND 90-DAY AVERAGE BLOOD GLUCOSE READINGS WITH THE CONTOUR® NEXT 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
    870029 CONTOUR® NEXT BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 9651E DP01T111P

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male