BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19998870 · Received August 17, 2024

    Report

    Report Number
    3003442380-2024-21449
    Event Type
    Malfunction
    Date Received
    August 17, 2024
    Date of Event
    June 16, 2024
    Report Date
    July 19, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018181
    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 1944524- MDR 3003442380-2024-21449 - DEVICE 3 OF 10.

    Description of Event or Problem · 0

    REFERENCE NUMBER:1944524. EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT, THE PATIENT FACED ISSUE OF 10 INFUSION TUBING LEAKAGE FROM THE SITE AFTER BEING IN USE FOR 1 DAY EACH FOR ALL EVENTS.THE ISSUE WAS RESOLVED BY REPLACING INFUSION SET AND RESUMING INSULIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044596 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 5416054 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male