BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20107253 · Received August 30, 2024

    Report

    Report Number
    3003442380-2024-23227
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 31, 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 1954534- MDR 3003442380-2024-23227- DEVICE 1 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 01-JUN-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET CANNULA WAS KINKED WITHIN 3 OR MORE HOURS AFTER INSERTION AT ABDOMEN, WHICH CAUSE THE PATIENT BLOOD GLUCOSE LEVELS WAS ELEVATED TO 540 MG/DL, THEREFORE PATIENT HAD RECEIVED CORRECTION BOLUS VIA PUMP AND TOOK MDI. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1803801 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003742

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male