BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19495699 · Received June 9, 2024

    Report

    Report Number
    3003442380-2024-07426
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    May 3, 2024
    Report Date
    June 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244014664
    PMA / PMN Number
    K061374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1883792 - DEVICE 1 OF 2. E1: PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INFUSION SETS FELL OFF DURING USE ON (B)(6) 2024 WHICH LED TO HIGH BLOOD GLUCOSE LEVEL OF 200 MG/DL. THE ISSUE GOT RESOLVED BY REPLACING THE INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. THE INFUSION SET IN USE FOR LESS THAN 1 DAY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124874 AUTOSOFT 30 INSET 30 2-PACK 60/13 GREY TCAP FPA UNOMEDICAL A/S 1000283 6004475 05705244014664

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female