BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19848377 · Received July 28, 2024

    Report

    Report Number
    3003442380-2024-17474
    Event Type
    Malfunction
    Date Received
    July 28, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 28, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1924832 - MDR 3003442380-2024-17474 - DEVICE 1 OF 9

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED KINGDOM PATIENT COMPLAINED ABOUT NINE INFUSION SETS THAT FELL OFF DURING USE. EVENT TOOK PLACE ON (B)(6)2024 AND (B)(6)2024. THE INFUSION SETS WERE IN USE FOR ONE DAY. PATIENT REPLACED INFUSION SETS FOE ALL THE EVENTS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775624 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6004600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown