BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19685869 · Received July 6, 2024

    Report

    Report Number
    3003442380-2024-12272
    Event Type
    Malfunction
    Date Received
    July 6, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026001
    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 1904798 - MDR 3003442380-2024-12272 - DEVICE 1 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER 1904798. EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 3 INFUSION SET FELL OFF EVENTS IN BETWEEN (B)(6) 2024 TO 17-MAY-2024. THE INFUSION SET WAS IN USE FROM 12 HOURS TO 2 DAYS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434316 AUTOSOFT XC INSET I 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1010900 6004222 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male