BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19495717 · Received June 9, 2024

    Report

    Report Number
    3003442380-2024-07425
    Event Type
    Malfunction
    Date Received
    June 9, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 9, 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 MDR 1883780 - DEVICE 5 OF 5. E1: PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT ENCOUNTERED FIVE INFUSION SET CANNULAS WERE KINKED WITHIN 3 OR MORE HOURS AFTER INSERTION WHICH LED TO HIGH BLOOD GLUCOSE LEVEL OF 300-458MG/DL. THE INSERTION SITE WAS AT ABDOMEN. THE PATIENT CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION AND REGULARLY ROTATED THE SITE LOCATION. THE ISSUE GOT RESOLVED BY CHANGING SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. THE INFUSION SET IN USE FOR 10 MIN - 3 DAYS. 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
    2326107 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003530 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female