BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21544533 · Received March 7, 2025

    Report

    Report Number
    3003442380-2025-03032
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 1, 2025
    Report Date
    April 10, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017931
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2025-03032. 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 6006558 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE (B)(4) ON 26/MAR/2025. THE REFERENCE SAMPLES WERE VISUAL INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE 2132830 COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6006558 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 78 AND PACKAGING IN THE MULTIVAC M12, ON 11/APR/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLING OF QUICKSET: THE LOT 4D00158 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 11/APR/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4D02476 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 15/APR/2024, WITH A TOTAL OF (B)(4) UNITS. GLUING TUBING: THE LOT 4D00031 WAS MANUFACTURED ACCORDING TO THE WI VERSION 41 GLUING IN THE LINE 8, ON 02/APR/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4D002477 WAS MANUFACTURED ACCORDING TO THE WI VERSION 41 GLUING IN THE LINE 8, ON 13/APR/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4A04798 WAS MANUFACTURED ACCORDING TO THE WI VERSION 41 GLUING IN THE LINE 4,5,8 ON 30/JAN/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 21/MAR/2025 AGAINST MALFUNCTION CODE 3 LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING) AND LOT 6006558 AND ANOTHER 1 COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6006558 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ANOTHER 1 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 CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 2 OF 2. E1: PATIENT CITY - (B)(6). PATIENT COUNTRY - UNITED STATES.

    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 THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET LEAKAGE EVENTS FROM (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
    435558 MINIMED QUICK-SET UNO QUICK-SET 110/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-398A 6006558 05705244017931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown