BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 17986791 · Received October 23, 2023

    Report

    Report Number
    1810909-2023-00228
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    September 28, 2023
    Report Date
    April 18, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003791604
    PMA / PMN Number
    K193407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED CONTOUR NEXT GEN 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

    THE CUSTOMER SERVICE RECEIVED THE SUSPECTED CONTOUR NEXT GEN METER. THE METER SWITCHED ON AS EXPECTED AND THE CUSTOMER SERVICE MODE WAS RUN THROUGH WHICH SHOWED ERROR MESSAGES. THE CUSTOMER SERVICE THEN PERFORMED AN IN-HOUSE TESTING WITH THE RETURNED METER AND IN-HOUSE CONTOUR NEXT TEST STRIPS AND IN-HOUSE CONTOUR NEXT CONTROL SOLUTION, WHICH GAVE A SATISFACTORY PERFORMANCE. 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 MODEL # (D4) WAS NOT PROVIDED.

    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 # 7916E AND UDI # (B)(4) WAS DISTRIBUTED OUTSIDE THE US. THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED ASCENISA CUSTOMER SERVICE FROM GREECE TO GET ASSISTANCE WITH HER CONTOUR NEXT GEN METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE 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.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED ASCENISA CUSTOMER SERVICE FROM GREECE TO GET ASSISTANCE WITH HER CONTOUR® NEXT METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143076 CONTOUR® NEXT BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7916E DP05R172P 05016003791604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female