BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19544553 · Received June 15, 2024

    Report

    Report Number
    3003442380-2024-08504
    Event Type
    Malfunction
    Date Received
    June 15, 2024
    Date of Event
    February 17, 2024
    Report Date
    June 16, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 3003442380-2024-08504 - DEVICE 8 OF 18.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADHESIVE ISSUES WITH 18 INFUSION SETS AND STATED THAT THE INFUSION SET FELL OFF DURING USE. THE SPECIFIC VALUE OF BLOOD GLUCOSE (BG) WAS UNKNOWN BUT DISPLAYED AS 'HIGH', AND THE PATIENT TOOK A CORRECTION INJECTION VIA MDI. THE EVENTS OCCURRED FROM 17-FEB-2024 TO 22-FEB-2024. THE PATIENT HAD HIGH/LARGE KETONES, BUT THE HEALTHCARE PROFESSIONAL (HCP) DID NOT IDENTIFY THEM AS DANGEROUS/LIFE-THREATENING. THE INFUSION SET WAS IN USE FOR 3 HOURS. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795019 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 5372006 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female