BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22191326 · Received June 11, 2025

    Report

    Report Number
    3003442380-2025-10536
    Event Type
    Injury
    Date Received
    June 11, 2025
    Date of Event
    May 23, 2025
    Report Date
    June 16, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6), PATIENT COUNTRY: CANADA.

    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: COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED FOR RECORD (B)(4) ON (B)(6) 2025. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001154 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 75 ON 28-APR-2023, 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 TRENDING: A QUERY WAS RUN IN DATABASE ON 16-JUN-2025 AGAINST HARM CODE SIGNS OF UNTREATED HYPOGLYCEMIA THAT PATIENT IS UNABLE TO SELF MANAGE REQUIRING INTERVENTION BY A HEALTH CARE PROFESSIONAL OR REQUIRES EMERGENCY ADVANCED LIFE, MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION NO MALFUNCTION DESCRIBE AND LOT 6001154 AND NO MORE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONLY ONE COMPLAINT RECEIVED ON THE LOT IN QUESTION AND HARM CODE, THE TEST ON REFERENCE SAMPLES WERE NOT TESTED SINCE A NO MALFUNCTION RELATED TO THE INFUSION SET WAS REPORTED, THEREFORE NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR 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 CANADA. IT WAS REPORTED THAT PATIENT WENT TO AN EMERGENCY ROOM AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPOGLYCEMIA EVENT. BLOOD GLUCOSE LEVEL WAS 2.2 MG/DL AT THE TIME OF THE EVENT. THE DURATION OF HOSPITALIZATION WAS FOR FOUR DAYS. PATIENT GOT TREATED WITH INSULIN VIA SYRINGE. 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
    2201470 MINIMED QUICK-SET UNO QUICK-SET 46/6 SC1 MCAN FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-394A600 6001154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H