BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20104692 · Received August 30, 2024

    Report

    Report Number
    3003442380-2024-23310
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    July 4, 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 1954470 - MDR 3003442380-2024-23310 - DEVICE 1 OF 2

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON 04-JUL-2024, REPORTED THAT PATIENT FACED 2 INFUSION SET CANNULA KINKED AFTER 3 OR MORE HOURS OF INSERTION FOR 2ND EVENT AND AFTER 3 HOURS OF INSERTION FOR 1ST EVENT. INSERTION SITE WAS ABDOMEN. CUSTOMER REGULARLY ROTATE SITE LOCATION. CUSTOMER CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE BLOOD GLUCOSE LEVEL WAS 290-300MG/DL FOR 1ST EVENT. CUSTOMER 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
    1597516 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6004990

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female