BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19787776 · Received July 21, 2024

    Report

    Report Number
    3003442380-2024-15495
    Event Type
    Malfunction
    Date Received
    July 21, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 21, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    00570524401815
    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) - 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 SETS FELL OFF DURING USE EVENTS ON 29-MAY-2024, 31-MAY-2024, AND 05-JUNE-2024. INFUSION SET HAS BEEN USED FOR LESS THAN 8HRS FOR ALL EVENTS. THE PATIENT RESOLVED THE EVENT BY REPLACING THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479808 AUTOSOFT 90 UNO INSET II 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002818 5408982 00570524401815

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female