BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22288792 · Received June 19, 2025

    Report

    Report Number
    3003442380-2025-10818
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    May 31, 2025
    Report Date
    July 1, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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 KINGDOM.

    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 6010783 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 (CUSTOMER STATES INFUSION SET LEAKS) (SOURCE/CAUSE CANNOT BE IDENTIFIED, ONLY USE WHEN A SPECIFIC MALFUNCTION CANNOT BE DETERMINED) COMPLAINT INVESTIGATION. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. REFERENCE SAMPLES TEST RESULTS: ON THE VISUAL INSPECTION ACCORDING TO WI VERSION 3, WAS PERFORMED AND 10/10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR FLOW ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR LEAK ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: PACKAGING LOT: THE LOT 6010783 WAS PACKAGING ACCORDING TO THE WI VERSION 82, IN THE LINE MULTIVAC 12 ON 14/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING THE LOT 4M01577 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF TUBING IN THE MACHINE MP04 AND MP08, ON 10/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L04951 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF TUBING IN THE MACHINE MP04 AND MP08, ON 08/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4M01581 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF TUBING IN THE MACHINE MP04 AND MP08, ON 13/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4M00061 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 IN THE GLUING OF TUBING IN THE MACHINE MP04 AND MP08, ON 08/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 19-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 6010783 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: ON THE INVESTIGATION ON REFERENCE SAMPLES, NO ISSUE WERE FOUND RELATED TO LEAK IN TUBING CONNECTORS, 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 UNITED KINGDOM. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. BLOOD GLUCOSE LEVEL WAS HIGH AT THE TIME OF THE EVENT. THEREFORE, PATIENT TOOK INSULIN PEN FOR THE TREATEMENT. 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
    1497620 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6010783 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown