BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19879836 · Received August 1, 2024

    Report

    Report Number
    3003442380-2024-18329
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    June 1, 2024
    Report Date
    August 1, 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

    (B)(4) - DEVICE 1 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT ON (B)(6) 2024 & (B)(6) 2024 SIX INFUSION SET FELL OFF DURING USE AND INFUSION SET IS LONG FOR FEW HOURS TO ONE DAY OF USE. THE BLOOD GLUCOSE LEVEL WAS 180-199 MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979592 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6005585

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male