BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19737542 · Received July 14, 2024

    Report

    Report Number
    3003442380-2024-14349
    Event Type
    Malfunction
    Date Received
    July 14, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 14, 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 1912466 - MDR 3003442380-2024-14349 - DEVICE 2 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED PATIENT FACED FOUR INFUSION SETS FELL OFF DURING USE EVENTS BETWEEN 15-APRIL-2024 TO 05-JUNE-2024. THE INFUSION SET WAS IN USE FOR 1.5 TO 2 DAYS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210931 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6004387 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male