BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19428674 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04607
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 4, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1875016- MDR 3003442380-2024-04607- DEVICE 2 OF 2.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET CANNULA CRIMPED EVENT ON (B)(6) 2024. THE EVENT OCCURRED 3 OR MORE HOURS AFTER INSERTION. THE INFUSION SET WAS IN USE FOR LESS THAN 12 HOURS.THE INSERTION SITE WAS AT SBDOMEN. THE BLOOD GLUCOSE LEVEL WAS 300 MG/DL. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIE 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
    1276000 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6004591

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female