BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19882176 · Received August 1, 2024

    Report

    Report Number
    3003442380-2024-18565
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    June 6, 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 1955099 - MDR 3003442380-2024-18565 - DEVICE 2 OF 3.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED SIMILAR EVENTS OF KINKED CANNULA WITH THREE INFUSION SETS AFTER BEING USED FOR LESS THAN A DAY. THE SYMPTOMS WERE NOTICED 3 OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION WAS REPORTED TO BE THIGH AND ARM AND THE SITE WAS ROTATED REGULARLY. PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 400 MG/DL SO PATIENT TOOK A CORRECTION BOLUS VIA PUMP. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. UNOMEDICAL DO NOT SEE 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
    2075907 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male