BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 22724123 · Received August 6, 2025

    Report

    Report Number
    3003442380-2025-12419
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    May 1, 2025
    Report Date
    September 27, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4), DEVICE 1 OF 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2025-12419. 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). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010193, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 26-SEP-2025 AGAINST "FINAL REPORTING DECISION EQUAL "SERIOUS INJURY" AND "DEATH", "LOT NUMBER" CRITERIA EQUAL "6010193". THE COUNT OF COMPLAINT IS 0 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010193 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE 49 ON 16/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 4L00272 WAS MANUFACTURED ACCORDING TO THE WI VERSION 8 AND MANUFACTURED IN THE MACHINE ITL01 ON 11/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L00282 WAS MANUFACTURED ACCORDING TO THE WI VERSION 8 AND MANUFACTURED IN THE MACHINE ITL01 ON 14/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L02714 WAS MANUFACTURED ACCORDING TO THE WI VERSION 65 AND MANUFACTURED IN THE MACHINE SC03 ON 13/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT A NON-CONFORMANCE NC WAS OPENED DURING THE STERILIZATION PROCESSES ACTIONS WERE REQUIRED. THEREFORE, DEVICE HISTORY RECORD (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 CANADA. IT WAS REPORTED THAT PATIENT FACED EVENTS WHERE THREE INFUSION SETS TUBING WAS BROKEN IN HALF BETWEEN (B)(6) 2025.THE INFUSION SETS WERE IN USE FOR LESS THAN 48 HOURS. PATIENT REPLACED INFUSION SETS 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
    1365398 INSET II UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002817 6010193 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male