BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 24066433 · Received January 14, 2026

    Report

    Report Number
    3003442380-2025-18387
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 11, 2025
    Report Date
    March 5, 2026
    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 2 OF 2.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 (B)(4) MDR 3003442380-2025-18387. 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: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH: A QUERY WAS RUN IN THE EQMS ON 04/MAR/2026 AGAINST "LOT NUMBER" "6014776" AND SIMILAR MALFUNCTION CODES: LEAK - TUBING DAMAGE SIGNIFICANT / EXTENSIVE, TUBING IS SPLIT (ALONG THE LENGTH OF THE TUBING) OR HAS PINHOLES. THE REVIEW CONFIRMED THAT LOT 6014776 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCRS) OR CORRECTIVE AND PREVENTIVE ACTION (CAPAS) OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 04/MAR/2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6014776" AND SIMILAR MALFUNCTION CODES: LEAK - TUBING DAMAGE SIGNIFICANT / EXTENSIVE, TUBING IS SPLIT (ALONG THE LENGTH OF THE TUBING) OR HAS PINHOLES. THE COUNT OF COMPLAINTS IS 1. THE COMPLAINTS NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6014776 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 125 AND MANUFACTURED IN THE LINE INSET 7, ON 31/JUL/2025 WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 5G04529 WAS MANUFACTURED ACCORDING TO WI VERSION 10 AND MANUFACTURED IN THE MACHINE ITL01, ON 30/JUL/2025 WITH A TOTAL OF (B)(4) UNITS. THE LOT 5G05558 WAS MANUFACTURED ACCORDING TO WI VERSION 10 AND MANUFACTURED IN THE MACHINE SC02, ON 29/JUL/2025 WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6014776 AND RELATED MALFUNCTION CODES FOR LEAKAGE. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT, BUT NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED ISSUES WITH TWO INFUSION SETS ON (B)(6) 2025. THE MIDDLE OF THE TUBING WAS KINKED. ONE INFUSION SET WAS IN USE FOR 1 HOUR AND OTHER INFUSION SET WAS USED FOR 2 HOURS. THE BLOOD GLUCOSE (BG) WAS HIGH WITH SPECIFIC VALUE UNKNOWN AND GOT TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI). 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
    134765 INSET II UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002817 6014776 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male