BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20133513 · Received September 4, 2024

    Report

    Report Number
    3003442380-2024-23792
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    July 31, 2024
    Report Date
    August 7, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    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 1961118- MDR 3003442380-2024-23792- DEVICE 1 OF 2.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(6). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CANNULA ISSUES WITH TWO INFUSION SETS. THE CANNULAS WERE KINKED. THE EVENT OCCURRED ON 31-JUL-2024. PATIENT NOTICED SYMPTOMS WITHIN 3 HOURS OF INSERTION. THE INSERTION OF SITE WAS THE ABDOMEN. PATIENT REGULARLY ROTATED SITE LOCATION. PATIENT CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. PATIENT 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870382 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 UNKNOWN 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female