BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19429651 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04705
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 10, 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 1875084- MDR 3003442380-2024-4705- DEVICE 1 OF 3. (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA KINKED ON (B)(6) 2024 AFTER 3 HOURS OF INSERTION. INSERTION SITE WAS ABDOMEN. THE GLUCOSE LEVEL WAS OVER 280 MG/DL. 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580795 AUTOSOFT 30 INSET 30 2-PACK 60/13 GREY TCAP FPA UNOMEDICAL A/S 1000283 6004065

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female