BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19819399 · Received July 24, 2024

    Report

    Report Number
    3003442380-2024-16082
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 14, 2024
    Report Date
    July 24, 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 1920039 - MDR 3003442380-2024-16082 - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED EVENT WITH TWO INFUSION SETS WHICH FELL OFF DURING PHYSICAL ACTIVITY ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 3 DAYS FOR ALL EVENTS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356068 AUTOSOFT 90 INSET II 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1000282 6005445 05705244014572

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male