BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20541266 · Received October 27, 2024

    Report

    Report Number
    3003442380-2024-29367
    Event Type
    Malfunction
    Date Received
    October 27, 2024
    Date of Event
    September 19, 2024
    Report Date
    September 27, 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 2021631, DEVICE 2 OF 8.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET 8 CANNULA KINKED EVENTS ON 19-SEP-2024 WITHIN 3 OR MORE HOURS AFTER INSERTION. THE INSERTION SITE WAS RIGHT/LEFT ABDOMEN, ONE ON EACH LEG, LOWER BACK, UPPER BUTTOCKS. THE BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF EVENTS THEREFORE, THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820273 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6005177 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female