BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19947105 · Received August 9, 2024

    Report

    Report Number
    3003442380-2024-20109
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    June 11, 2024
    Report Date
    July 10, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1935274 - MDR 3003442380-2024-20109 - DEVICE 2 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED KINKED CANNULA EVENT ON (B)(6) 2024. THE EVENT OCCURRED AFTER THREE HOURS OF INSERTION. THE INFUSION SET WAS IN USE FOR 4 HOURS. THE INFUSION SET WAS INSERTED IN ABDOMEN. BLOOD GLUCOSE LEVELS DURING THE EVENT WERE 280 MG/DL. THE PATIENT TOOK CORRECTION BY TAKING BOLUS VIA PUMP TO ADDRESS THE EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. COMPANY 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634987 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 UNKNOWN 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male