BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 21423700 · Received February 20, 2025

    Report

    Report Number
    1810909-2025-00028
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 29, 2025
    Report Date
    May 14, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003734700
    PMA / PMN Number
    K223293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 SECTIONS A2 AND A4 AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. CONTOUR® NEXT METER IS SIMILAR TO THE CONTOUR® NEXT GEN METER AVAILABLE IN THE US MARKET. THE CONTOUR® NEXT TEST STRIPS WITH SKU # 7347 AND LOT # 3MPEF04C HAS THE 510K# OF K223293 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® NEXT METER WITH SERIAL # (B)(6) FOR EVALUATION. THE TEST STRIPS ASSOCIATED WITH THE EVENT WERE NOT RETURNED. THE RETURNED METER AND THE IN-HOUSE CONTOUR® NEXT TEST STRIPS FROM LOT # 3MPEF04C WERE USED FOR IN-HOUSE TESTING, USING BLOOD SPIKED WITH GLUCOSE AT 22.3 MMOL/L AND 7.4 MMOL/L, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS. ADDITIONALLY, THE RETURNED METER WAS TESTED WITH THE IN-HOUSE STRIPS MENTIONED ABOVE AND THE IN-HOUSE CONTOUR® NEXT CONTROL SOLUTION FROM LOT # 4BV2G24, AND THE RESULTS WERE WITHIN THE ACCEPTABLE CONTROL RANGES. THE IN-HOUSE TESTING WAS ALSO PERFORMED BEFORE THE METER WAS RETURNED USING THE CONTOUR® NEXT METER WITH SERIAL # (B)(6) AND IN-HOUSE CONTOUR® NEXT TEST STRIPS FROM LOT # 3MPEF04C, USING BLOOD SPIKED WITH GLUCOSE AT 21.9 MMOL/L AND 7.5 MMOL/L, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS.

    Description of Event or Problem · 0

    THE CUSTOMER FROM SWITZERLAND REPORTED THAT WITHIN TWO MINUTES, SHE OBTAINED BLOOD GLUCOSE READINGS OF 27 MMOL/L, 11.3 MMOL/L AND 6.3 MMOL/L WITH THE CONTOUR® NEXT METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. THE CUSTOMER WAS OFFERED A REPLACEMENT METER, HOWEVER, THE CUSTOMER DECLINED THE OFFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394548 CONTOUR® NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7347 3MPEF04C 05016003734700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female