BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 18111072 · Received November 10, 2023

    Report

    Report Number
    1810909-2023-00236
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    October 17, 2023
    Report Date
    April 25, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003792014
    PMA / PMN Number
    K193407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR NEXT GEN METER FOR EVALUATION. NO TEST STRIPS WERE RETURNED. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED METER AND IN-HOUSE CONTOUR NEXT TEST STRIPS USING BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE. THE BLOOD GLUCOSE READINGS OBTAINED WITH THE IN-HOUSE TESTING WERE PROPERLY STORED IN THE METER'S MEMORY.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: SECTIONS B5, D1 (BRAND NAME) AND D4 (MODEL #, CATALOG # AND LOT #) HAVE BEEN UPDATED. 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. CONTOUR® NEXT METER IS SIMILAR TO THE CONTOUR® NEXT GEN METER AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE NBW AND 510 (K) # K193407 ASSOCIATED WITH THE CONTOUR® NEXT GEN METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. CONTOUR® NEXT METER WITH SKU # 7920E AND UDI # (B)(4) WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    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 MODEL # (D4) WAS NOT PROVIDED.

    Description of Event or Problem · 0

    AN ADVOCATE FROM AUSTRALIA CALLED ON BEHALF OF HER CHILD TO REPORT THAT THEIR BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR® NEXT METER.

    Description of Event or Problem · 0

    AN ADVOCATE FROM AUSTRALIA CALLED ON BEHALF OF HER CHILD TO REPORT THAT THEIR BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR NEXT GEN METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE ADVOCATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103927 CONTOUR® NEXT BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7920E PH22050006 05016003792014

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female