BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22050526 · Received May 20, 2025

    Report

    Report Number
    3003442380-2025-09213
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    April 24, 2025
    Report Date
    June 17, 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: FRANCE. H11:SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED LOT NUMBER, EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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), LEAKAGE FROM CONNECTION OF HUB TO THE RESERVOIR. THE BATCH 6001967 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WI-002702 GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 03 AND WI-002688 GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 02 FOR THE IDD-PMC02.04 LEAKAGE FROM CONNECTION OF HUB TO THE RESERVOIR. 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 6001967 WAS MANUFACTURED ACCORDING TO THE WI VERSION 77, MANUFACTURED IN THE MACHINE M12, ON 26/JUN/2023 WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY DHR REVIEW: THE LOT 3F03088 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26, MANUFACTURED IN THE LINE ASSEMBLY QUICK SET, ON 24/JUN/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03087 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26, MANUFACTURED IN THE LINE ASSEMBLY QUICK SET, ON 24/JUN/2023 WITH A TOTAL OF (B)(4) UNITS. GLUING TUBING DHR REVIEW: THE LOT 3F03638 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE 05 ON 28/JUN/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03639 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE 08, ON 22/JUN/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03078 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38, MANUFACTURED IN THE MACHINE 05, ON 20/JUN/2023 WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 16/JUN/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM CONNECTION OF HUB TO THE RESERVOIR AND LOT 6001967 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 (B)(4). EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT INFUSION SET WAS LEAKING FROM THE CONNECTION OF HUB TO THE CATHETER/RESERVOIR ON (B)(6) 2025. 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
    2142523 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-397A 6001967 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown