BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19901262 · Received August 3, 2024

    Report

    Report Number
    3003442380-2024-18809
    Event Type
    Malfunction
    Date Received
    August 3, 2024
    Date of Event
    June 25, 2024
    Report Date
    September 6, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016927
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2024-18809. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H11: INVESTIGATION SUMMARY: THE INFORMATION OF THIS COMPLAINT HAS BEEN EVALUATED. 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 POST MARKETING SURVELLIENCE (PMS) PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD HAVE FLAGGED ON THE TRIPS AND ALERTS ACCORDING TO THE MARKET QUALITY REVIEW PROCEDURE (OMQR)

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1931665- MDR 3003442380-2024-18809 - DEVICE 3 OF 3.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 3 INFUSION SETS ADHESIVE ON (B)(6) 2024. THE INFUSION SET FELL OFF WHILE BEING IN USE FOR ONE DAY FOR 2 SETS AND 1 FOR 2 DAYS WHILE DOING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING. THE ISSUE WAS RESOLVED BY REPLACING INFUSION SET AND RESUMING INSULIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384997 AUTOSOFT XC UNO INSET I 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001728 6004075 05705244016927

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male