BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20106439 · Received August 30, 2024

    Report

    Report Number
    3003442380-2024-23498
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    June 15, 2024
    Report Date
    August 1, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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 1955689 - MDR 3003442380-2024-23498 - DEVICE 4 OF 4 H11: SINCE NO LOT NUMBER IS AVAILABEL, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON 15-JUNE-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED FOUR INFUSION SETS CANNULA KINKED EVENTS WITHIN 3 HOURS AFTER INSERTION. THE SITE OF LOCATION WAS ABDOMEN. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355364 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female