BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 21983536 · Received May 8, 2025

    Report

    Report Number
    3003442380-2025-08379
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 8, 2025
    Report Date
    September 30, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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. REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010050 WAS MANUFACTURED ACCORDING TO THE WORK INSRTUCTION (WI) VERSION 29 AND MANUFACTURED IN THE LINE 1 ON 31/OCT/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 RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (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 OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT EXPERIENCED AN EVENT OF INFUSION SET CANNULA WHICH WAS LAYING ON TOP OF SKIN INSTEAD OF INSERTING UNDER SKIN ON (B)(6) 2025. THE EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. 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
    1103111 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002825 6010050 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female