BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINMED QUICK SET

    MDR report key: 20851586 · Received December 5, 2024

    Report

    Report Number
    3003442380-2024-33577
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 6, 2024
    Report Date
    April 25, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CITY: (B)(6). PATIENT COUNTRY: HONG KONG.

    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 6004002 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 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO 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 6004002 WAS MANUFACTURED ACCORDING TO THE WI VERSION 77 MANUFACTURED IN THE LINE MULTIVAC 08, ON 02/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY OF QUICK SET: THE LOT 3K03762 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE LINE ASSEMBLY OF QUICK-SET, ON 25/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3K04929 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 MANUFACTURED IN THE LINE ASSEMBLY OF QUICK-SET, ON 01/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. THE GLUING TUBE LOT 3K02796 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 MANUFACTURED IN THE LINE PEGADO 04,05 AND 08, ON 24/OCT/2023, WITH A TOTAL OF (B)(4). THE GLUING TUBE LOT 3K04910 WAS MANUFACTURED ACCORDING TO THE WI VERSION 40 MANUFACTURED IN THE LINE PEGADO 04, ON 01/NOV/2023, WITH A TOTAL OF (B)(4). 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 24/APR/2025 AGAINST MALFUNCTION LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING) AND LOT 6004002 AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABSE FOR THE SAME LOT 6004002 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM REPORTED, 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 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 HONG KONG. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE ON (B)(6) 2024. THE LEAKAGE WAS IN THE TUBING. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS 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
    2059772 MINMED QUICK SET UNO QUICK-SET 110/9 SC1 MECA  FPA UNOMEDICAL A/S MMT-396A 6004002 05705244018051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown