BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 23276048 · Received October 14, 2025

    Report

    Report Number
    3003442380-2025-14919
    Event Type
    Malfunction
    Date Received
    October 14, 2025
    Date of Event
    September 17, 2025
    Report Date
    December 19, 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

    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 18-DEC-2025 AGAINST "LOT NUMBER 6010435 AND SIMILAR MALFUNCTION CODE(S): LEAK BETWEEN TUBING AND SITE CONNECTOR -DETACHMENT / SIGNIFICANT WETNESS, TUBING DETACHED FROM TUBING-TUBING CONNECTOR. THE REVIEW CONFIRMED THAT LOT 6010435 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 18-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6010435 AND SIMILAR MALFUNCTION CODES: LEAK BETWEEN TUBING AND SITE CONNECTOR -DETACHMENT / SIGNIFICANT WETNESS, TUBING DETACHED FROM TUBING-TUBING CONNECTOR. THE COUNT OF COMPLAINT IS 0. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010435 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120 AND MANUFACTURED IN THE LINE 1 ON 30/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING: THE LOT 4L01260 WAS MANUFACTURED ACCORDING TO THE WI VERSION 08 AND MANUFACTURED IN THE MACHINE ITL01, ON 30/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L03497 WAS MANUFACTURED ACCORDING TO THE WI VERSION 08 AND MANUFACTURED IN THE MACHINE ITL01, ON 30/NOV/2024, 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 6010435 AND RELATED MALFUNCTION CODES FOR TUBING DETACHED FROM TUBING-TUBING CONNECTOR. NO OTHER MORE 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

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON 17-SEP-2025. THE SITE OF DETACHMENT WAS FROM CONNECTOR. THE INFUSION SET WAS IN USE FOR TWENTY FOUR HOURS. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183506 INSET II UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002817 6010435 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown