BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20165153 · Received September 7, 2024

    Report

    Report Number
    3003442380-2024-24461
    Event Type
    Malfunction
    Date Received
    September 7, 2024
    Date of Event
    July 30, 2024
    Report Date
    September 8, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244021099
    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 1963717- MDR 3003442380-2024-24461- DEVICE 1 OF 6.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 30-JULY-2024, IT WAS REPORTED BY THE PATIENT THAT SIX INFUSIONS SET CANNULA WAS KINKED AFTER 3 HOURS OF INSERTION. INFUSION SET WAS PLACED IN ABDOMEN. PATIENT REPLACED 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346610 AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US FPA UNOMEDICAL A/S 1003912 6005576 05705244021099

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male