BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19663310 · Received July 3, 2024

    Report

    Report Number
    3003442380-2024-11660
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    January 10, 2024
    Report Date
    July 3, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    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 1901289 - MDR 3003442380-2024-11660 - DEVICE 1 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED SIMILAR EVENTS OF LEAKAGE WITH SIX INFUSION SETS WHERE INFUSION SET TUBING WAS LEAKING AT THE CANNULA HOUSING OUT ONTO THE PATCH. THE INFUSION SET WAS USED FOR APPROXIMATELY 24 HOURS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579476 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 UNKNOWN 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male