BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET 30

    MDR report key: 23130159 · Received September 24, 2025

    Report

    Report Number
    3003442380-2025-14072
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 24, 2025
    Report Date
    October 8, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    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: COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003916, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003916 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 25 AND MANUFACTURED IN THE LINE L1 ON 25-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 3H04828 WAS MANUFACTURED ACCORDING TO THE WI VERSION 28 AND MANUFACTURED IN THE MACHINE L1, ON 22-OCT-2023, 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 THE PATIENT FACED INFUSION SET INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS AT THE SITE. THE INSERTION SITE WAS ABDOMEN. THE EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES 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
    532287 INSET 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002825 6003916

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female