BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19475496 · Received June 6, 2024

    Report

    Report Number
    3003442380-2024-06497
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    April 11, 2024
    Report Date
    June 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    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 1880784 - MDR 3003442380-2024-06497 - DEVICE 2 OF 4. (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET CANNULA KINKED EVENTS, FIRST ON (B)(6) 2024. ALL THE EVENTS OCCURRED WITHIN 3 HOURS OF INSERTION AND THE INSERTION SITE WAS AT ABDOMEN. THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 230 TO 350 MG/DL AND THE PATIENT RESOLVED IT BY CHANGING SOFT CANNULA INFUSION SET AND RESUMED INSULIN 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
    1862875 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 6002758 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female