BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19473279 · Received June 5, 2024

    Report

    Report Number
    3003442380-2024-05924
    Event Type
    Malfunction
    Date Received
    June 5, 2024
    Date of Event
    March 5, 2024
    Report Date
    June 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018365
    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- 1881333 - MDR 3003442380-2024-05924 - DEVICE 2 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THE PATIENT FACED A CRIMPED CANNULA ON (B)(6) 2024. THE BLOOD GLUCOSE OF THE PATIENT WAS ABOVE 500 MG/DL. THE SITE WAS PATIENT'S ABDOMEN. 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
    2054320 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002825 6004144 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male