BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21906897 · Received April 25, 2025

    Report

    Report Number
    3003442380-2025-07171
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    February 25, 2025
    Report Date
    June 18, 2025
    Manufacturer
    UNOMEDICAL UM-D
    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

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

    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 MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). THE BATCH 6000502 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 FOR THE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). 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. FUNCTIONAL (LEAK TEST) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000502 WAS PACKAGED ACCORDING TO THE WI VERSION 75, MANUFACTURED IN THE MACHINE M12, ON 13/APR/2023 WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY DHR REVIEW: THE LOT 3C07016 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26, MANUFACTURED IN THE LINE ASSEMBLY QUICK SET, ON 11/APR/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3C07017 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26, MANUFACTURED IN THE LINE ASSEMBLY QUICK SET, ON 12/APR/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3C07018 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26, MANUFACTURED IN THE LINE ASSEMBLY QUICK SET, ON 12/APR/2023 WITH A TOTAL OF (B)(4) UNITS. GLUE TUBING DHR REVIEW: THE LOT 3C05573 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE GLUING 08, ON 11/APR/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3C06998 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE GLUING 05, ON 11/APR/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3C05567 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE GLUING 04, ON 02/APR/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3C07002 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE GLUING 05, ON 12/APR/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3C07001 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE GLUING 04, ON 12/APR/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3C06999 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE GLUING 08, ON 12/APR/2023 WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 18/JUN/2025 AGAINST MALFUNCTION CODE EVALUATED LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING) AND LOT 6000502 AND NO OTHER COMPLAINT 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: 2179075. EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT INFUSION SET WAS LEAKING AT THE QUICK RELEASE SITE AT BUTTOCKS ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR ONE HOUR. NO FURTHER INFORMATION WAS 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
    476240 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-397A 6000502 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown