BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19846795 · Received July 27, 2024

    Report

    Report Number
    3003442380-2024-17085
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    June 16, 2024
    Report Date
    July 28, 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 1924714- MDR 3003442380-2024- 17085- DEVICE 1 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS FELL OFF EVENTS ON 16-JUN-2024 AND 19-JUN-2024. INFUSION SET HAD BEEN IN USE FOR 1 DAY. BLOOD GLUCOSE LEVEL WAS NOTICED 146 MG/DL AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776492 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 6005182

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male