BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 19431628 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04670
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 18, 2024
    Report Date
    May 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1875006.

    Description of Event or Problem · 0

    'UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, ON 18-APR-2024, , THE PATIENT REPORTED THAT THE INFUSION SET CANNULA WAS KINKED, WITH 3 SETS OF INFUSION AND SYMPTOMS PATIENT FACES WITHIN 3 HOURS OF INSERTION. THE INFUSION SITE USED FOR INSERTION IS ABDOMEN. THE BLOOD GLUCOSE WAS GOES UPTO 385 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
    330015 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002825 6004144

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male