BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21675669 · Received March 24, 2025

    Report

    Report Number
    3003442380-2025-04471
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 22, 2025
    Report Date
    April 24, 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

    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 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 BATCH 5413182 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: THE REFERENCE SAMPLES FOR THE LOT 5413182 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL INSPECTION IN THE 1733767 ON 02/SEP/2023. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE (B)(4) COMPLAINT TEST REPORT. THE REFERENCE SAMPLES FOR THE LOT 5413182 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR FLOW AND LEAK IN THE 1961677 ON 14/MAR/2025. 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: THE PACKAGING LOT 5413182 WAS MANUFACTURED ACCORDING TO THE WI VERSION 73 MANUFACTURED IN THE LINE MULTIVAC 12, ON 25/JAN/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 5414429 WAS MANUFACTURED ACCORDING TO THE WI VERSION 25 MANUFACTURED IN THE LINE ASSEMBLY OF QUICK-SET, ON 25/JAN/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 5414430 WAS MANUFACTURED ACCORDING TO THE WI VERSION 25 MANUFACTURED IN THE LINE ASSEMBLY OF QUICK-SET, ON 25/JAN/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY LOT 5414431 WAS MANUFACTURED ACCORDING TO THE WI VERSION 25 MANUFACTURED IN THE LINE ASSEMBLY OF QUICK-SET, ON 26/JAN/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 13/MAR/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS AND LOT 5413182 AND NO ANOTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER AND MALFUNCTION CODE. ANOTHER QUERY WAS RUN IN DATABASE ON 24/APR/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS AND LOT 5413182 AND ANOTHER 1 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, 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 CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: (B)(6). PATIENT COUNTRY - HONG KONG.

    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 HONG KONG. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE LEAKAGE WAS AT THE QUICK RELEASE. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740033 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 5413182 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown