BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19474480 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06398
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018365
    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 1880687 - DEVICE 13 OF 17. E1: PATIENT CITY: (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 SEVENTEEN INFUSION SET CANNULA BENT EVENTS, FIRST ON (B)(6) 2024 AND OTHER WITHIN LAST 2 WEEKS. ALL THE EVENTS OCCURRED WITHIN 3 HOURS OF INSERTION AND THE INSERTION SITE WAS AT ABDOMEN. THE BLOOD GLUCOSE LEVEL AT THE TIME OF FIRS EVENT WAS NORMAL AND OTHER EVENTS WAS 485MG/DL. THE PATIENT RESOLVE ALL THE EVENTS BY CHANGING SOFT CANNULA INFUSION SET AND RESUMED INSULIN 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861795 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002825 6004147 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male