BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19590796 · Received June 22, 2024

    Report

    Report Number
    3003442380-2024-09703
    Event Type
    Malfunction
    Date Received
    June 22, 2024
    Date of Event
    May 6, 2024
    Report Date
    June 22, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016712
    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 1893444 - DEVICE 1 OF 2

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 23 MAY 2024, IT WAS REPORTED THAT PATIENT EXPERIENCED THAT THE INFUSION SET CANNULA WAS KINKED. THE PATIENT REPORTED TWO INFUSION SETS HAD KINKED CANNULA ISSUE. ON (B)(6) 2024, WITHIN 3 HOURS OF ABDOMEN INSERTION FIRST EVENT OCCURRED AND SECOND EVENT OCCURRED 3 OR MORE HOURS AFTER ABDOMEN INSERTION ON (B)(6) 2024.THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 201 MG/DL FOR FIRST EVENT AND FOR SECOND EVENT 376 MG/DL. ADDITIONALLY, LOCATION SITE WAS REGULARLY ROTATED. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163707 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 UNKNOWN 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male