BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21052492 · Received January 2, 2025

    Report

    Report Number
    3003442380-2024-35679
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 5, 2024
    Report Date
    April 30, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    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: HONG KONG.

    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. THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED HAS BEEN EVALUATED HAS BEEN EVALUATED FOR THE MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). THE LOT 6001974 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE). COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES FOR LOT 6001974 WERE PREVIOUSLY TESTED IN COMPLAINT (B)(4) ON 22/FEB/2024. TEST RESULTS: VISUAL TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WORK INSTRUCTION (WI) VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL LEAK TEST 2 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING OF QUICK SET THE LOT 6001974 WAS MANUFACTURED ACCORDING TO THE WI VERSION 77 AND PACKAGING IN THE MULTIVAC 12, ON 29/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY OF QUICK SET: THE LOT 3F04122 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 29/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F04123 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 29/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F04124 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 30/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF QUICK SET THE LOT 3F03640 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP05, ON 28/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F04708 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP05, ON 27/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03637 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP08, ON 28/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F04136 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP05, ON 27/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F04132 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP08, ON 29/JUN/2023, 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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 22/APR/2025 AGAINST MALFUNCTION LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING) AND LOT 6001974 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABSE FOR THE SAME LOT 6001974 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM REPORTED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR 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 HONG KONG. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT OF INFUSION SET WAS LEAKING AT THE TUBING OR QUICK RELEASE ON 05-DEC-2024. 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
    1396625 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6001974 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown