BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® XT

    MDR report key: 24967429 · Received April 23, 2026

    Report

    Report Number
    1810909-2026-00021
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K191286
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER CONTACT INFORMATION WAS NOT PROVIDED, THEREFORE NO CONTACT INFORMATION WAS CAPTURED IN SECTION E1. UNKNOW WAS CAPTURED IN SECTION A1 AND NO INFORMATION WAS CAPTURED IN SECTIONS A2 AND A4 AS THE CUSTOMER'S CREDENTIALS, AGE AND WEIGHT WERE NOT PROVIDED. NO INFORMATION WAS CAPTURED IN SECTION D4 (MODEL #, CATALOG #, SERIAL #, KIT LOT # AND UDI #) AND H4 (DEVICE MANUFACTURE DATE) COULD NOT BE DETERMINED AS NO PRODUCT INFORMATION WAS PROVIDED. GUDID INFORMATION DOES NOT EXISTS, AS THE CUSTOMER DID NOT PROVIDE THE PRODUCT INFORMATION. CONTOUR® XT METER IS SIMILAR TO THE CONTOUR® NEXT EZ METER AVAILABLE IN THE US MARKET. THEREFORE, DEVICE PRODUCT CODE AS NBW HAS BEEN CAPTURED IN SECTION D2B AND 510K # HAS BEEN CAPTURED AS K191286 IN SECTION G4.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL (HCP) FROM SWITZERLAND CONTACTED ON BEHALF OF THE CUSTOMER TO REPORT THAT THE CUSTOMER¿S CONTOUR® XT METER WAS DISPLAYING THE UNITS OF MEASUREMENT ACCOMPANIED WITH THE BLOOD GLUCOSE READINGS IN MG/DL INSTEAD OF MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE HCP DECLINED THE OFFER OF REPLACEMENT METER KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456082 CONTOUR® XT BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female