BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19591127 · Received June 22, 2024

    Report

    Report Number
    3003442380-2024-09919
    Event Type
    Malfunction
    Date Received
    June 22, 2024
    Date of Event
    May 10, 2024
    Report Date
    June 22, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1894403 - MDR 3003442380-2024-09919 - DEVICE 2 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET CANNULA WAS KINKED ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS DISPLAYED HIGH AND WAS MANAGED BY MULTIPLE DAILY INJECTIONS (MDI). THE EVENT OCCURED 3 OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION WAS AT ABDOMEN FOR FIRST THREE EVENTS AND AT THIGH FOR THE FOURTH EVENT. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103276 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 5398091 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male