BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19495659 · Received June 9, 2024

    Report

    Report Number
    3003442380-2024-07444
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244014572
    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 1883863- MDR 3003442380-2024-07444- DEVICE 1 OF 3

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT THREE INFUSION SET TUBING WAS DETACHED FROM HUB WITHIN 24 HOURS OF USE. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107002 AUTOSOFT 90 INSET II 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1000282 UNKNOWN 05705244014572

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female