BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22032851 · Received May 16, 2025

    Report

    Report Number
    3003442380-2025-08968
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 22, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 6001720 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 2092654 ON 07-FEB- 2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR STATIC PULL TUBING-TUBING CONNECTOR. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001720 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 PACKAGED IN THE M08, ON 30/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 3F00281 WAS GLUED ACCORDING TO THE WI VERSION 26, ASSEMBLY ON 30/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F04594 WAS GLUED ACCORDING TO THE WI VERSION 26, ASSEMBLY ON 25/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: THE LOT 4905078 WAS GLUED ACCORDING TO THE WI VERSION 38, LINE 4, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03068 WAS GLUED ACCORDING TO THE WI VERSION 38, MACHINE MP04, 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, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 21/MAY/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6001720 AND ONE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6001720 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVILLENCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: BRAMPTON. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    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 CANADA. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING DETACHED FROM CONNECTORON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR COUPLE OF HOURS. THE INSERTION SITE WAS ARM THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749289 MINIMED QUICK-SET UNO QUICK-SET 80/9 SC1 MCAN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-386A600 6001720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown