BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19603609 · Received June 25, 2024

    Report

    Report Number
    3003442380-2024-10106
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    April 23, 2024
    Report Date
    June 25, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1896172 - DEVICE 6 OF 14. PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN ISSUE WITH APPROXIMATELY THIRTEEN INFUSIONS SETS CANNULAS WERE KINKED. THE SYMPTOMS WERE NOTICED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN, UPPER BUTTOCKS, SIDE OF WAIST AT BACK. THE TEN INFUSION SETS WITHIN THE PAST FEW WEEKS AND ADDITIONAL THREE ON SAME DAY AND HAVE BEEN NOTICED THE ISSUE 'A COUPLE WEEKS AGO' (B)(6) 2024. THE BLOOD GLUCOSE LEVEL WAS BETWEEN 345MG/DL. THE INFUSION SET WAS IN USE FOR BOTH EVENTS FOR ABOUT ONE DAY. THE PATIENT REPLACED 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
    284382 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003997 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male