BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 22076204 · Received May 23, 2025

    Report

    Report Number
    3003442380-2025-09744
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    February 20, 2025
    Report Date
    July 11, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244021099
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY: COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD COMPLAINT (B)(4) ON 10-JUL-2025. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010214 MANUFACTURED ACCORDING TO THE DOCUMENT 79 ON 12-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED TRENDING: A QUERY WAS RUN IN DATABASE ON 09/JUL/2025 AGAINST MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, HARM CODE MILD TO MODERATE DIABETIC KETOACIDOSIS WHICH THE PATIENT IS ABLE TO SELF MANAGE AND LOT 6010214 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABSE FOR THE SAME LOT, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODEAND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS AND HAD LARGE KETONES ON (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219890 AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US FPA UNOMEDICAL DEVICES S.A. DE C.V. 1003912 6010214 05705244021099

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Required Intervention