BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET II

    MDR report key: 24143721 · Received January 22, 2026

    Report

    Report Number
    3003442380-2026-00097
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 8, 2026
    Report Date
    February 27, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018303
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2026-00097), WAS SUBMITTED ON 22-JAN-2026. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 10-MAR-2025. 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 26-FEB-2026 AGAINST "LOT NUMBER" "6012198" AND SIMILAR MALFUNCTION CODES: OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS- BLOCKAGE, OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED), TUBING IS DAMAGED (E.G., KINKED, DEFORMED, TWISTED, COLLAPSED, OR PINCHED). THE REVIEW CONFIRMED THAT LOT 6012198 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NONCONFORMING REPORTS (NCR)S OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH: A QUERY WAS RUN IN THE EQMS ON 26-FEB-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6012198" AND SIMILAR MALFUNCTION CODES: OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS- BLOCKAGE, OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED), TUBING IS DAMAGED (E.G., KINKED, DEFORMED, TWISTED, COLLAPSED, OR PINCHED). THE COUNT OF COMPLAINTS IS 1. THE COMPLAINTS NUMBERS ARE (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6012198 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 121 AND MANUFACTURED IN THE LINE INSET 1, ON 10-MAR-2025 WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 5B04541 WAS MANUFACTURED ACCORDING TO WI VERSION 9 AND MANUFACTURED IN THE MACHINE IGTL01, ON 05-MAR-2025 WITH A TOTAL OF (B)(4) UNITS. THE DHR REVIEW INDICATED THAT DURING OUTGOING TEST 4(C), ONE SAMPLE WAS FOUND TO HAVE A CONTAMINATION. AN EXTENDED SAMPLING WAS CONDUCTED AND ACCEPTED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. THEREFORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW IDENTIFIED MINOR FINDINGS. THEY WERE MANAGED ACCORDING TO PROCEDURE AND DID NOT IMPACT COMPLIANCE; 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). COMPLAINT UNCONFIRMED: FOLLOWING INVESTIGATION, THE REPORTED FAILURE COULD NOT BE CONFIRMED FOR THIS COMPLAINT. 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 6012198 AND RELATED MALFUNCTION CODES FOR DETACHMENT. 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

    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 STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INSULIN FLOW BLOCKED ALARM DUE TO OCCLUSION ISSUE EVENT ON (B)(6) 2026. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206646 INSET II UNO INSET II 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002823 6012198 05705244018303

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male