BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20047513 · Received August 23, 2024

    Report

    Report Number
    3003442380-2024-22310
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    May 19, 2024
    Report Date
    July 26, 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 1950568- MDR 3003442380-2024-22310- DEVICE 1 OF 2. SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). 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 19-MAY-2024. PATIENT NOTICED SYMPTOMS WITHIN 3 OR MORE HOURS AFTER INSERTION. INFUSION SET WAS USED FOR LESS THAN 24 HOURS. THE SITE OF INSERTION WAS UPPER BUTTOCKS, ABDOMEN, HIPS, ARM. PATIENT REGULARLY ROTATED THE SITE LOCATION. PATIENT CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. BLOOD GLUCOSE LEVEL WAS 600 MG/DL AT THE TIME OF THE EVENT. THEREFORE, PATIENT TOOK CORRECTION INJECTION VIA MDI FOR THE TREATMENT. PATIENT REPLACED THE INFUSION SET AND SUCCESSFULLY RESUMED INSULIN DELIVERIES. 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
    1312238 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1001683 UNKNOWN 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female