BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 24186968 · Received January 27, 2026

    Report

    Report Number
    3003442380-2026-00127
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    December 31, 2025
    Report Date
    March 18, 2026
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K991759
    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 (3003442380-2026-00127), WAS SUBMITTED ON 27-JAN-2026. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 24-JAN-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 11-MAR-2026 AGAINST "LOT NUMBER" "6011271 " 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 6011271 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 11-MAR-2026 AGAINST "LOT NUMBER" CRITERIA EQUAL "6011271" 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 6011271 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MACHINE MULTIVAC 12, ON 24-JAN-2025 WITH A TOTAL OF (B)(4). GLUE-TUBING LOT: THE LOT 5A00997 WAS MANUFACTURED ACCORDING TO WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04 AND MP08, ON 15-JAN-2025 WITH A TOTAL OF (B)(4). THE LOT 5A00999 WAS MANUFACTURED ACCORDING TO WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04 AND MP08, ON 17-JAN-2025 WITH A TOTAL OF (B)(4). THE DHR REVIEW INDICATED THAT DURING OUTGOING TEST 9(C), TWO SAMPLES WERE FOUND TO HAVE A CONTAMINATION AND RAISED CANNULA. 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. 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 6011271 AND RELATED MALFUNCTION CODES FOR OCCLUSION. 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 SAUDI ARABIA. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCAKGE WAS IN THE TUBING. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40592 QUICK SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-396A 6011271 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown