BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 25149690 · Received May 12, 2026

    Report

    Report Number
    1810909-2026-00026
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 12, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K191286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE HCP PERFORMED CONTROL TESTS WITH THE SUSPECTED CONTOUR® XT AND THE RESULTS WERE WITHIN SPECIFICATIONS. SINCE NO PRODUCT INFORMATION WAS PROVIDED AND THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION, NO TESTING COULD BE PERFORMED AND A DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE REPORTER INFORMATION (E1) WAS NOT PROVIDED. UNKNOWN WAS CAPTURED IN SECTION A1 AND NO INFORMATION WAS CAPTURED IN SECTIONS A2, A3 AND A4 AS THE CUSTOMER'S INITIALS, AGE, SEX AND WEIGHT WERE NOT PROVIDED. THE CUSTOMER DID NOT PROVIDE THE PRODUCT INFORMATION FOR THE CONTOUR® NEXT TEST STRIPS, THEREFORE NO INFORMATION WAS CAPTURED IN SECTION D4 (MODEL #, CATALOG #, LOT # AND EXPIRATION DATE), AND THE DEVICE MANUFACTURE DATE (H4) COULD NOT BE DETERMINED. THE CONTOUR® NEXT TEST STRIP ARE USED WITH THE CONTOUR® XT METER WHICH IS SIMILAR TO THE CONTOUR® NEXT EZ METER AVAILABLE IN THE US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K191286 ASSOCIATED WITH THE CONTOUR® NEXT EZ METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL (HCP) FROM FINLAND CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT A BLOOD GLUCOSE READINGS OF 6.9 MMOL/L WAS OBTAINED WITH THE CONTOUR® XT METER AND 3.3 MMOL/L WAS OBTAINED WITH THE LABORATORY TESTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97501 CONTOUR® NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown