BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21793935 · Received April 8, 2025

    Report

    Report Number
    3003442380-2025-05677
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 6, 2025
    Report Date
    July 18, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 INFORMATION IN THIS COMPLAINT (B)(4) WITH OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). THE BATCH 6010034 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 03 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 02 OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED). COMPLAINT INVESTIGATION: TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL (FLOW TEST) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010034 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82, PACKAGED IN THE MACHINE M12, ON 29/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY DHR REVIEW: THE LOT 4K05685 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27, MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 29/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05686 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27, MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 29/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. GLUE TUBING DHR REVIEW: THE LOT 4E01515 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE US05-US06, ON 20/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4E01516 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE US05-US06, ON 28/OCT/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 17/JUL/2025 AGAINST MALFUNCTION CODE EVALUATED OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6010034 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES RELATED TO THE COMPLAINT, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO OTHER COMPLAINT RECEIVED ON 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    604737 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6010034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown