BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21053168 · Received January 2, 2025

    Report

    Report Number
    3003442380-2024-35441
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    November 19, 2024
    Report Date
    May 28, 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: BRAZIL.

    Additional Manufacturer Narrative · 0

    THE INFORMATION IN THIS COMPLAINT (B)(4), HAS BEEN EVALUATED TUBING DETACHED FROM TUBING-TUBING CONNECTOR. THE BATCH 6003966 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL TEST (STATIC PULL TEST) ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003966 WAS MANUFACTURED ACCORDING TO THE WI VERSION 45 MANUFACTURED IN THE LINE/MACHINE MULTIVAC 12, ON 28/OCT/2023 WITH A TOTAL OF 57,000 UNITS. ASSEMBLY DHR REVIEW: THE LOT 3K03766 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE MACHINE SC1, ON 28/OCT/2023 WITH A TOTAL OF 29,200 UNITS. THE LOT 3K03767 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE MACHINE SC1, ON 29/OCT/2023 WITH A TOTAL OF 29,200 UNITS. THE LOT 3K03769 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE MACHINE SC1, ON 29/OCT/2023 WITH A TOTAL OF 29,200 UNITS. GLUE TUBING DHR REVIEW: THE LOT 3K02798 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 MANUFACTURED IN THE MACHINE AUTOMATIC GLUING 04,05,08, ON 27/OCT/2023, WITH A TOTAL OF 239,200 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 (B)(6) 2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6003966 AND OTHER 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, OTHER 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN BRAZIL. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2024. THE SITE OF INSERTION WAS ABDOMEN. NO FURTHER INFORMATION 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
    1375483 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A 6003966 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown