BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22391800 · Received July 3, 2025

    Report

    Report Number
    3003442380-2025-11237
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 14, 2025
    Report Date
    September 4, 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: THE 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: 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 6010578, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010578 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND MANUFACTURED IN THE MACHINE MULTIVAC 12 ON 02/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY LOT: THE LOT 4L04953 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 02/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L04955 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 02/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L05415 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 02/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. GLUE-TUBING LOT: THE LOT 4L04838 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08 ON 01/DEC/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L04835 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE MP04, MP08 ON 28/NOV/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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: 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 THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2025. THE SITE OF DETACHMENT WAS TUBING CONNECTOR. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR LESS THAN A DAY. THE BLOOD GLUCOSE LEVEL WAS 350MG/DL AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA CORRECTION BOLUS VIA PUMP. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    1491590 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397A 6010578 05705244017573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown