BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® XT

    MDR report key: 22028581 · Received May 15, 2025

    Report

    Report Number
    1810909-2025-00078
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 25, 2025
    Report Date
    June 11, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K191286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. DURING THE FOLLOW-UP, THE CUSTOMER STATED THAT THEY ARE STILL USING THE SUSPECTED CONTOUR® XT METER AND IT IS FUNCTIONING AS EXPECTED. SINCE THE PRODUCT DETAIL WAS NOT PROVIDED, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED.

    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. NO PRODUCT INFORMATION WAS PROVIDED BY THE CUSTOMER; THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (MODEL #, SERIAL # AND METER KIT LOT #) AND SECTION H4 (DEVICE MANUFACTURE DATE). THE CONTOUR® XT METER 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

    THE CUSTOMER FROM IRELAND REPORTED THAT ONE OF HIS BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR® XT METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011107 CONTOUR® XT BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male