BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK SET

    MDR report key: 23483406 · Received November 6, 2025

    Report

    Report Number
    3003442380-2025-15811
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 10, 2025
    Report Date
    November 27, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: SPAIN.

    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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6011587 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011587 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGING IN THE MULTIVAC M12 ON 15-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: ASSEMBLY THE LOT 5B00447 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND ASSEMBLED IN THE QUICKSET LINE, ON 14-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B00448 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND ASSEMBLED IN THE QUICKSET LINE, ON 14-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5B00440 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE LINE MP04 AND MP08, ON 13-FEB-2025, 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. REVIEW OF THE DHR SHOWED THAT DURING THE OUTGOING TEST 6 AN EXTENDED WAS FOUND FOR CONTAMINATION IN ONE SAMPLE AND THEREFORE THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: 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 CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025 DUE TO WHICH PATIENT FACED HYPERGLYCEMIA EVENT.THE BLOCKAGE WAS IN THE TUBING.THE PATIENT WAS TREATED WITH PEN. 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
    2487510 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6011587 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown