BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK-SET

    MDR report key: 22780112 · Received August 12, 2025

    Report

    Report Number
    3003442380-2025-12711
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 23, 2025
    Report Date
    October 4, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    PMA / PMN Number
    K991759
    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 PER REVISION 21 OF PROCEDURE 3709030, A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DEVICE HISTORY RECORD (DHR) REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD 2347443 THE BATCH 6010289, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010289 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGING IN THE MACHINE MULTIVAC 12 ON 16-NOV-2024, WITH A TOTAL OF 57,000 UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 4L01686 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 15-NOV-2024, WITH A TOTAL OF 29,200 UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 4L01687 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 15-NOV-2024, WITH A TOTAL OF 29,200 UNITS. THE SUB-ASSEMBLY, ASSEMBLY OF QUICK SET OF THE LOT 4K06118 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 AND MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 17-NOV-2024, WITH A TOTAL OF 5,000 UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 4L00864 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-05-08, ON 07-NOV-2024, WITH A TOTAL OF 150,000 UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 4K06568 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-05-08, ON 05-NOV-2024, WITH A TOTAL OF 70,000 UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 4K05680 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-05-08, ON 30-OCT-2024, WITH A TOTAL OF 60,000 UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 4K05679 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-05-08, ON 29-OCT-2024, WITH A TOTAL OF 120,000 UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 4L00863 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-05-08, ON 06-NOV-2024, WITH A TOTAL OF 150,000 UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 4K06701 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 08, ON 06-NOV-2024, WITH A TOTAL OF 1,800 UNITS. THE SUB-ASSEMBLY, TUBE GLUING OF THE LOT 4L01862 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04-05-08, ON 13-NOV-2024, WITH A TOTAL OF 150,000 UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 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.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    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 FACED AN INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364707 QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6010289 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown