BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22257757 · Received June 18, 2025

    Report

    Report Number
    3003442380-2025-10789
    Event Type
    Malfunction
    Date Received
    June 18, 2025
    Date of Event
    June 4, 2025
    Report Date
    August 1, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017573
    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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6002729 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL (FLOW) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002729 WAS MANUFACTURED ACCORDING TO THE WI VERSION 77 PACKAGED IN THE MULTIVAC 12, ON 14/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 3H00387 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 14/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00388 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 14/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00725 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE LINE ASSEMBLY OF QUICK SET, ON 14/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING TUBING DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 3H00363 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE MACHINE MP08, ON 12/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00361 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE MACHINE MP08, ON 13/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00364 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE MACHINE GLUING 4, ON13/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3H00365 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE MACHINE GLUING 5, ON 11/AUG/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3G03005 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 MANUFACTURED IN THE MACHINE GLUING 4, ON 14/AUG/2023, WITH A TOTAL OF (B)(4) 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 WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 31/JUL/2025 AGAINST MALFUNCTION CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6002729 AND NO OTHER 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 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.

    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 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
    1527398 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6002729 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown