BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21111694 · Received January 9, 2025

    Report

    Report Number
    3003442380-2024-36571
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 15, 2024
    Report Date
    February 26, 2025
    Manufacturer
    UNOMEDICAL A/S
    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

    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.THE BATCH 6001720 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 1 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 1 FOR THE CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. VISUAL TEST ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL STATIC PULL OF THE TUBING-TUBING CONNECTOR TEST 1 FLOW ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001720 WAS MANUFACTURED ACCORDING TO THE 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 06/FEB/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6001720 AND NO OTHER 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: CANADA.

    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 PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2024. THE SITE OF DETACHMENT WAS CONNECTION BETWEEN TUBING AND QUICK RELEASE. INSERTION SITE WAS ABDOMEN. THE INFUSION SE WAS IN USE FOR TWO DAYS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421988 MINIMED QUICK-SET UNO QUICK-SET 110/9 SC1 MCAN FPA UNOMEDICAL A/S MMT-396A600 6001720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown