BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22123048 · Received June 2, 2025

    Report

    Report Number
    3003442380-2025-10090
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 18, 2025
    Report Date
    September 5, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244017450
    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: AUSTRALIA.

    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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010576, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010576 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MACHINE MULTIVAC 12 ON 09/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY LOT: THE LOT 4L04948 WAS ASSEMBLED ACCORDING TO (WI) VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 09/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L04949 WAS ASSEMBLED ACCORDING TO (WI) VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 09/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L04950 WAS ASSEMBLED ACCORDING TO (WI) VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 09/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 4L06525 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08 ON 05/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4M00058 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08 ON 06/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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: ONE EXTENDED WAS RAISED DURING THE PROCESS UNRELATED TO THE MALFUNCTION REPORTED, THEREFORE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT 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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED AN INSULIN FLOW BLOCKED ALARM ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. 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
    578813 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL A/S MMT-399A 6010576 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown