BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19826804 · Received July 25, 2024

    Report

    Report Number
    3003442380-2024-16762
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    May 19, 2024
    Report Date
    July 25, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    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 1921343 - MDR 3003442380-2024-16762 - DEVICE 6 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 6 INFUSION SETS CANNULA KINKED EVENTS BETWEEN 19-MAY-2024 TO 17-JUNE-2024. THE PATIENT NOTICED SYMPTOMS THREE OR MORE HOURS AFTER INSERTION. THE INFUSION SETS HAS BEEN USED FOR THREE HOURS TO 1 DAY. INSERTION SITE WAS UPPER BUTTOCKS. PATIENT REGULARLY ROTATE SITE LOCATION. FURTHERMORE, PATIENT CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE BLOOD GLUCOSE LEVEL WAS 240-300 MG/DL AT THE TIME OF EVENTS. 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351155 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 UNKNOWN 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male