BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 21749904 · Received April 2, 2025

    Report

    Report Number
    3003442380-2025-05039
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    February 19, 2025
    Report Date
    June 12, 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: UNITED STATES. INITIAL AND FINAL MDR (B)(4) - DEVICE 2 OF 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4). 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 6010032 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 3.0 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2.0 FOR THE CODE ADD MALFUNCTION CODE. 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 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL LEAK TEST 2 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING OF QUICK SET. THE LOT 6010032 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82 AND PACKAGING IN THE MULTIVAC 12, ON 29/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY OF QUICK SET: THE LOT 4K05682 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 28/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05683 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 28/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K06592 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 30/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05698 WAS MANUFACTURED ACCORDING TO THE WI VERSION 27 ASSEMBLED IN THE QUICKSET LINE, ON 02/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF QUICK SET THE LOT 4K05238 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP08, ON 26/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05680 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP05, MP08, ON 30/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05113 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF QUICK SET MACHINE MP04, MP08, ON 25/OCT/2024, 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 05/JUN/2025 AGAINST MALFUNCTION CODE LEAKAGE (CUSTOMER STATES INFUSION SET LEAKS) (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED) AND LOT 6010032 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 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, NO OTHER 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

    (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED THREE INFUSION SET WAS LEAKING ON (B)(6) 2025. THE INFUSION SET WAS IN USE FOR 10 YEARS. 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
    686903 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL UM-D MMT-397A 6010032 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown