BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 23070444 · Received September 17, 2025

    Report

    Report Number
    3003442380-2025-13862
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 21, 2025
    Report Date
    September 26, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018242
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED MANUFACTURING DATE UNDER H4. 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 6010091, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010091 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 118 AND MANUFACTURED IN THE LINE L-6 ON 04-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 4K04692 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED IN THE MACHINE SC04, ON 21-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 4K00319 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED IN THE MACHINE SC02, ON 08-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 4K00328 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED IN THE MACHINE SC01, ON 10-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 4K01341 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED IN THE MACHINE SC04, ON 19-OCT-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 4L00925 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED IN THE MACHINE SC04, ON 05-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 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 EXPERIENCED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. 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
    2504669 INSET II UNO INSET II 60/6 PINK TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002821 6010091 05705244018242

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male