BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 21014861 · Received December 25, 2024

    Report

    Report Number
    3003442380-2024-35194
    Event Type
    Malfunction
    Date Received
    December 25, 2024
    Date of Event
    September 21, 2024
    Report Date
    November 26, 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 (B)(4), DEVICE 3 OF 12.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT THE PATIENT FACED TWELVE INFUSION SETS CANNULA KINKED EVENTS ON 09-SEP-2024, 15-SEP-2024, 21-SEP-2024, 30-SEP-2024, 12-OCT-2024, 17-OCT-2024, 20-OCT-2024, 25-OCT-2024, 25-OCT-2024, 31-OCT-2024, 03-NOV-2024, AND 12-NOV-2024. THE EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. COMPANY 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109758 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6003650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown