BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19494812 · Received June 8, 2024

    Report

    Report Number
    3003442380-2024-07294
    Event Type
    Malfunction
    Date Received
    June 8, 2024
    Date of Event
    April 8, 2024
    Report Date
    June 8, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022386
    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 1883638 - MDR 3003442380-2024-07294 - DEVICE 2 OF 2. E1: 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 THE PATIENT FACED AN ISSUE WITH TWO INFUSIONS SET CANNULAS WERE KINKED. THE EVENTS OCCURRED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS BACK OF ARM AND UPPER BUTTOCKS. THE EVENT OCCURRED 3 WEEKS AGO AND 1 WEEKS AGO. THE PATIENT REPORTED CURRENT HIGH BLOOD GLUCOSE LEVEL OF 250-320 MG/DL VALUE. 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
    1265789 AUTOSOFT XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 6004834 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male