BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22640289 · Received July 29, 2025

    Report

    Report Number
    3003442380-2025-11917
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    June 30, 2025
    Report Date
    July 16, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018051
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 FOR THE MALFUNCTION NO MALFUNCTION BASED ON COMPLAINT INFORMATION. THE BATCH 6011751 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011751 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 82 PACKGING, ON 28/FEB/2023, 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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON (B)(6) 2025 AGAINST MALFUNCTION NO MALFUNCTION BASED ON COMPLAINT INFORMATION, HARM UNTREATED DIABETIC KETOACIDOSIS WHICH THE PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY AN HCP OR REQUIRES EMERGENCY ADVANCED LIFE SUPPORT TO PREVENT PERMANENT ORGAN DAMAGE AND LOT 6011751 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ANOTHER 1 COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WENT TO AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO DIABETIC KETOACIDOSIS (DKA) EVENT. BLOOD GLUCOSE LEVEL WAS 411 MG/DL AT THE TIME OF THE EVENT AND PATIENT GOT TREATED WITH INTRAVENOUS DRIP MANUAL INJECTION. THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. PATIENT WAS EXPERIENCED THE SYMPTOMS OF SICK/UNWELL, AND EXTREMITY PAIN/CRAMPS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476098 MINIMED QUICK-SET UNO QUICK-SET 110/9 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-396A 6011751 05705244018051

    Patients

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