BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 90

    MDR report key: 22086264 · Received May 27, 2025

    Report

    Report Number
    3003442380-2025-09836
    Event Type
    Injury
    Date Received
    May 27, 2025
    Date of Event
    January 15, 2025
    Report Date
    July 11, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018150
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) MDR 3003442380-2025-09836. 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 INVESTIGATIONS. A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD COMPLAINT (B)(4) ON 10-JUL-2025. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010027 MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 118 ON 08-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 INFECTION REQUIRES PRESCRIPTIVE TREATMENT E G ORAL ANTIBIOTICS AND LOT 6010027 AND ONE MORE 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 CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 1 OF 2.

    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 OCCURED IN THE UNITED STATES. THIS MDR IS BEING SUBMITTED FOR AN UNKNOWN QUANTITY OF INFUSION SETS THAT HAD THE REPORTED ISSUE. ON (B)(6) 2025, THE PATIENT REPORTED DEVELOPING AN INFECTION AT THE SITE WHERE THEIR INFUSION SET WAS INSERTED. THE PATIENT CONSULTED THEIR HEALTHCARE PROVIDER (HCP) ABOUT THE INFECTION. IT WAS NOTED THAT THE INFUSION SET HAD ONLY BEEN IN USE FOR 8 HOURS WHEN THE INFECTION WAS DETECTED. AS A RESULT OF THIS ISSUE, THE PATIENT'S BLOOD GLUCOSE LEVELS BECAME ELEVATED, THOUGH THE EXACT VALUE WAS NOT SPECIFIED; THE METER SIMPLY DISPLAYED 'HIGH'. TO ADDRESS THE HIGH BLOOD GLUCOSE, THE PATIENT ADMINISTERED A CORRECTION DOSE OF INSULIN USING A MULTIPLE DAILY INJECTION (MDI) METHOD. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014512 AUTOSOFT 90 UNO INSET II 110/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002818 6010027 05705244018150

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Required Intervention