BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFTÂ XC

    MDR report key: 19871472 · Received July 31, 2024

    Report

    Report Number
    3003442380-2024-18060
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    June 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 1926517 - MDR 3003442380-2024-18060 - DEVICE 3 OF 4.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 4 INFUSION SET CANNULA KINKED EVENT ON 04-JUN-2024 AFTER 3 HOURS OF INSERTION. INSERTION SITE WAS ABDOMEN. CUSTOMER REGULARLY ROTATE SITE LOCATION. THE GLUCOSE LEVEL WAS 160-170 MG/DL. FURTHERMORE, CUSTOMER CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959243 AUTOSOFTÂ XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 6004836

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male