BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21134983 · Received January 13, 2025

    Report

    Report Number
    3003442380-2024-36762
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 15, 2024
    Report Date
    April 30, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017573
    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: 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 6001591 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. THE REFERENCE SAMPLES FOR LOT 6001591 WERE PREVIOUSLY TESTED IN COMPLIANT 1861732 ON 08/MAY/2024. TEST RESULTS: VISUAL TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL LEAK TEST 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING OF QUICK SET. THE LOT 6001591 WAS MANUFACTURED ACCORDING TO THE WI VERSION 75 AND PACKAGING IN THE MULTIVAC 12, ON 31/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY OF QUICK SET: THE LOT WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 31/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 ASSEMBLED IN THE QUICKSET LINE, ON 26/APR/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF QUICK SET THE LOT 3E04497 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP08, ON 30/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E05397 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP08, ON 30/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E04499 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP04, ON 30/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3E05554 WAS MANUFACTURED ACCORDING TO THE WI VERSION 38 IN THE GLUING OF QUICK SET MACHINE MP05, ON 30/MAY/2023, 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 09/APR/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS (REFERS TO CONNECTORS IN BOTH ENDS OF THE TUBING) AND LOT 6001156 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6001591 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 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 EVENT ON (B)(6) 2024. THE LEAKAGE WAS AT THE QUICK RELEASE. 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
    499414 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-397A 6001591 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown