BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 21982753 · Received May 8, 2025

    Report

    Report Number
    3003442380-2025-08229
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 10, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244026032
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: 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. INITIAL AND FINAL MDR 2192500 - MDR 3003442380-2025- 08229 - DEVICE 5 OF 8.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED EVENTS OF CRIMPED CANNULA FROM (B)(6) 2025. THE ISSUES OCCURRED WITH EIGHT SIMILAR TYPES OF INFUSION SETS. THE SYMPTOMS OCCURRED WITHIN THREE HOURS OF INSERTION. THE SITE WAS PATIENT'S ABDOMEN, BUTTOCKS, LEGS, ARMS. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS ABOVE 500 MG/DL WHICH WAS TREATED WITH CHANGING INFUSION SETS MULTIPLE TIMES BEFORE TAKING BOLUS. THE CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997783 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL DEVICES S.A. DE C.V. 1010899 UNKNOWN 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female