BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22138619 · Received June 4, 2025

    Report

    Report Number
    3003442380-2025-10267
    Event Type
    Injury
    Date Received
    June 4, 2025
    Date of Event
    May 20, 2025
    Report Date
    July 9, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    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.

    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 6010035 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE REFERENCE SAMPLES FOR THE LOT 6010035 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL INSPECTION AND TESTED FOR FLOW IN THE COMPLAINT (B)(4) ON 20/JUN/2025. ALL TEST RESULTS WERE FOUND WITHIN SPECIFICATIONS AS PER THE TEST REPORT COMPLAINT 2180718 TEST REPORT. 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 WORK INSTRUCTION (WI) VERSION 3 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING THE LOT 6010035 WAS PACKAGING ACCORDING TO THE WI VERSION 82, IN THE MACHINE MULTIVAC 12, ON 30/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING THE LOT 4K05238 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42, IN THE MACHINE MP04 AND MP08, ON 26/OCT/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05239 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42, IN THE MACHINE MP04, MP05 AND MP08, ON 28/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 09/JUL/2025 AGAINST MALFUNCTION CODE TUBING IS DAMAGED (E.G., KINKED, DEFORMED, TWISTED,COLLAPSED, OR PINCHED) AND LOT 6010035 AND ONE ANOTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: ON THE INVESTIGATION ON REFERENCE SAMPLES, NO ISSUE WERE FOUND RELATED TO TUBING ISSUES, HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO MORE COMPLAINT WAS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION, NO FURTHER ACTION ARE REQUIRED, 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED HOSPITALIZATION DUE TO INFUSION SET TUBING WAS KINKED LEADING TO HYPERGLYCEMIA ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH 3 SALINE BAGS AND INSULIN BY INJECTION. 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
    673488 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-399A 6010035 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention