BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21803068 · Received April 9, 2025

    Report

    Report Number
    3003442380-2025-05745
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 9, 2025
    Report Date
    June 10, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    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: COLOMBIA.

    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 REFERENCE SAMPLES FOR THE LOT 6009136 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 2142002 ON 13/APR/2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK TEST. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT 2142002. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6009136 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 47 MANUFACTURED IN THE MACHINE MULTIVAC 12, ON 11/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY DHR REVIEW: THE LOT 4J00878 WAS MANUFACTURED ACCORDING TO THE WI 4905245 VERSION 27 MANUFACTURED IN THE LINE QUICKSET ASSEMBLY, ON 11/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05031 WAS MANUFACTURED ACCORDING TO THE WI 4905245 VERSION 27 MANUFACTURED IN THE LINE QUICKSET ASSEMBLY, ON 23/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. GLUE TUBING DHR REVIEW: THE LOT 4J00850 WAS MANUFACTURED ACCORDING TO THE WI 4905078 VERSION 42 MANUFACTURED IN THE MACHINE 04-05-08, ON 11/SEP/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K03295 WAS MANUFACTURED ACCORDING TO THE WI 4905078 VERSION 42 MANUFACTURED IN THE MACHINE 04-05-08, ON 19/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K03296 WAS MANUFACTURED ACCORDING TO THE WI 4905078 VERSION 42 MANUFACTURED IN THE MACHINE 04-05-08, ON 21/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K01560 WAS MANUFACTURED ACCORDING TO THE WI 4905078 VERSION 42 MANUFACTURED IN THE MACHINE 04-05-08, ON 16/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K04376 WAS MANUFACTURED ACCORDING TO THE WI 4905078 VERSION 42 MANUFACTURED IN THE MACHINE 05, ON 19/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K01661 WAS MANUFACTURED ACCORDING TO THE WI 4905078 VERSION 42 MANUFACTURED IN THE MACHINE 04-08, ON 19/OCT/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K03299 WAS MANUFACTURED ACCORDING TO THE WI 4905078 VERSION 42 MANUFACTURED IN THE MACHINE 04-05-08, ON 23/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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 10/JUN/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS AND LOT 6009136 AND NO FOUND 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, 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 OR CORRECTIVE AND PREVENTIVE ACTION (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 COLOMBIA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THAT THERE WAS A LEAKAGE IN THE TUBING ON (B)(6) 2025. IT WAS ALSO REPORTED THAT THE INFUSION SET GOT DAMAGE, WHICH RESULTED IN ELEVATED BLOOD GLUCOSE (285 MG/DL), THE INFUSION SET WAS IN USE FOR ONE DAY. 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
    1454082 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6009136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown