BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19936595 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19566
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    May 1, 2024
    Report Date
    July 9, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016958
    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 1933996 - MDR 3003442380-2024-19566 - DEVICE 5 OF 5.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FIVE INFUSION SETS CANNULA KINKED EVENTS, WITHIN THE PAST MONTH AND A HALF AND RECENTLY ON 1-JUL-2024 AND 2-JUL-2024. ALL THE EVENTS OCCURRED AFTER 3 HOURS OF INSERTION AND THE INSERTION SITE FOR ALL EVENTS WAS BETWEEN BREAST AREA AND ABDOMEN. THE SET WAS IN USE FOR 3 TO 4 HOURS. THE BLOODS GLUCOSE LEVEL AT THE TIME OF ALL EVENTS WAS HIGH (SPECIFIC VALUE UNKNOWN) AND PATIENT RESOLVED IT WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI) FOLLOWED BY CHANGING INFUSION SET AND RESUMED INSULIN 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398753 AUTOSOFT XC UNO INSET I 110/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001729 6000963 05705244016958

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female