BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19428226 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04663
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 9, 2024
    Report Date
    May 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1874995 MDR 3003442380-2024-04663- DEVICE 4 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET CAME OFF DURING USE ON (B)(6) 2024. THE BLOOD GLUCOSE LEVEL OF THE PATIENT AT THE TIME OF EVENT WAS 210 MG/DL. THE ISSUE OCCURED WITH FOUR SIMILAR INFUSION SETS USED FOR SIX HOURS.THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234571 AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1000281 6003320

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female