BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19431194 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04841
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    March 30, 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 1875077 - DEVICE 12 OF 16.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED SIXTEEN INFUSION SET WAS FELL OFF DURING USE EVENT. THE BLOOD GLUCOSE LEVEL WAS 240-270 MG/DL AT THE TIME OF EVENT. SOME INFUSION SETS WERE IN USE LESS THAN 3 - 4 HOURS AND OTHERS WERE LESS THAN 24 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453374 AUTOSOFT 90 UNO INSET II 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002818 5389997

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male