BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19490209 · Received June 7, 2024

    Report

    Report Number
    3003442380-2024-06851
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    March 1, 2024
    Report Date
    June 7, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018396
    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 1881983 - DEVICE 6 OF 7.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT THE INFUSION SET CANNULA WAS KINKED. WITHIN 3 HOURS OF THIGH INSERTION CUSTOMER NOTICED SYMPTOMS. BEGINNING AROUND (B)(6) 2024, THE PATIENT EXPERIENCED PROBLEMS WITH SEVEN INFUSION SETS OVER THE COURSE OF THE PREVIOUS TWO MONTHS. ADDITIONALLY, LOCATION SITE WAS REGULARLY ROTATED. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967272 AUTOSOFT 30 UNO INSET 30 110/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002826 UNKNOWN 05705244018396

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female