BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19677858 · Received July 5, 2024

    Report

    Report Number
    3003442380-2024-11822
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    May 25, 2024
    Report Date
    July 5, 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 1903574 - MDR 3003442380-2024-11822 - DEVICE 2 OF 2

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6) ON (B)(6)2024 AND (B)(6)2024, IT WAS REPORTED THAT PATIENT FACED 2 EVENTS OF INFUSION SET FELL OFF DURING USE. THE EVENTS OCCURRED WITHIN 3 HOURS TO 1 DAY OF INSERTION. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132773 AUTOSOFT XC INSET I 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1010900 6003931 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male