BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET

    MDR report key: 22662824 · Received July 30, 2025

    Report

    Report Number
    3003442380-2025-12050
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 16, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    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. THE REFERENCE SAMPLES FOR THE LOT 6009051 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT 2201535 ON 14-JUL-2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. IN ADDITIONAL TEST IS FOUND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: PACKAGING LOT: THE LOT 6009051 WAS PACKAGING ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 81, IN THE MACHINE MULTIVAC 12, ON 08/SEP/2024, WITH A TOTAL OF (B)(4) UNITS. WELDING LOT: THE LOT 4H04670 WAS MANUFACTURED ACCORDING TO THE WI VERSION 64, IN THE MACHINE US05 AND US06, ON 06/SEP/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 15/JUL/2025 AGAINST MALFUNCTION CODE LEAKAGE (CUSTOMER STATES INFUSION SET LEAKS) (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED) AND LOT 6009051 AND NO MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, 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 CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6) PATIENT COUNTRY: UNITED ARAB EMIRATES.

    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 ARAB EMIRATES. IT WAS REPORTED THAT PATIENT EXPERIENCED INFUSION SET LEAKAGE ISSUE ON (B)(6) 2025. THE SET HAD BEEN IN USE FOR ONE DAY. THIS ISSUE OF LEAKAGE LED TO AN INCREASE IN BLOOD GLUCOSE LEVEL WHICH WAS TREATED WITH INSULIN PUMP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45750 QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6009051 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown