BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19846601 · Received July 27, 2024

    Report

    Report Number
    3003442380-2024-17376
    Event Type
    Malfunction
    Date Received
    July 27, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 26, 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 1923597 - MDR 3003442380-2024-17376- DEVICE 6 OF 6.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 01-APR-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET CANNULA WAS KINKED WITHIN 3 HOURS AFTER INSERTION AT ABDOMEN, WHICH CAUSE THE PATIENT BLOOD GLUCOSE ELEVATED TO HIGH, THEREFORE PATIENT HAD RECEIVED CORRECTION BOLUS VIA PUMP. THE PATIENT REPLACED 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
    1733301 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003740

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male