BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20721380 · Received November 19, 2024

    Report

    Report Number
    3003442380-2024-31699
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 10, 2024
    Report Date
    October 21, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 2042897 - MDR 3003442380-2024-31699 - DEVICE 1 OF 3.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT, THE PATIENT EXPERIENCED 3 INFUSION SETS CANNULA WERE KINKED ON (B)(6) 2024, WITHIN 3 OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION WAS ABDOMEN. THIS ISSUE LED TO AN INCREASE IN BLOOD GLUCOSE LEVEL OF 503 MG/DL AND TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION. 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
    1307398 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 606319 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male