BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19591557 · Received June 23, 2024

    Report

    Report Number
    3003442380-2024-09860
    Event Type
    Malfunction
    Date Received
    June 23, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 23, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018242
    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 1894540 - MDR 3003442380-2024-09860 - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET FELL OFF EVENTS ON (B)(6) 2024. BLOOD GLUCOSE LEVELS WERE 7.5 MMOL/L AT THE TIME OF EVENT. THE SET WAS IN USE FOR LESS THAN A DAY. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103299 AUTOSOFT 90 UNO INSET II 60/6 PINK TCAP 10PK INT FPA UNOMEDICAL A/S 1002821 6000583 05705244018242

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male