BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19339044 · Received May 17, 2024

    Report

    Report Number
    3003442380-2024-02061
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Report Date
    January 18, 2026
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER 1864206. EVENT OCCURRED IN THE UNITED STATES. ON 05 APRIL 2024, IT WAS REPORTED THAT THE INFUSION SET CANNULA WAS BENT. THE INSERTION SITE WAS AT ABDOMEN. THE ISSUE WAS OCCURRED WITHIN 3 HOURS OF INSERTION. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES 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
    2530816 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNKNOWN 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown