BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19736678 · Received July 13, 2024

    Report

    Report Number
    3003442380-2024-13979
    Event Type
    Malfunction
    Date Received
    July 13, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 13, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    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 (B)(4) MDR (B)(4).13979- DEVICE 1 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4).. EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SET CANNULA KINKED EVENTS ON 24-MAY-2024. 31-MAY-2024 AND 03-JUN-2024. THE EVENT OCCURRED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS AT STOMACH. THE PATIENT REPLACED INFUSION SET AND REMAINED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862307 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6004405 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female