BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED QUICK-SET

    MDR report key: 19348256 · Received May 18, 2024

    Report

    Report Number
    3003442380-2024-02509
    Event Type
    Injury
    Date Received
    May 18, 2024
    Date of Event
    April 15, 2024
    Report Date
    August 8, 2025
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED DATE OF EVENT UNDER D3, BRAND NAME UNDER D1, EXPIRATION DATE, , SERIAL NUMER, MODEL NUMBER 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 REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002450 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 77, ON 26/JUL/2023 IN M12, 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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 08/AUG/2025 AGAINST MALFUNCTION CODE NO MALFUNCTION BASED ON COMPLAINT INFORMATION, HARM CODE UNTREATED DIABETIC KETOACIDOSIS WHICH THE PATIENT IS UNABLE TO SELF MANAGE REQUIRING INTERVENTION BY A HEALTH CARE PROVIDER (HCP) OR REQUIRES EMERGENCY ADVANCED LIFE SUPPORT TO PREVENT PERMANENT ORGAN DAMAGE (ELEVATED BLOOD GLUCOSE LEVEL, PRESENCE OF KETONES AND SYMPTOMS E.G.,NAUSEA, VOMITING, ABDOMINAL PAIN, CONFUSION) AND LOT 6002450 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, NO OTHER 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.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND WAS HOSPITALIZED. BLOOD GLUCOSE LEVEL OF PATIENT WAS 574 MG/DL. IT WAS TREATED WITH MANUAL INJECTION AT THE HOSPITAL. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 AT 6:00AM FOR TWO DAYS. THE KETONES TEST CONFIRMED THAT THE KETONES WERE NOT BAD. 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
    1162336 MINIMED QUICK-SET UNO QUICK-SET 60/6 SC1 MECA FPA MMT-399A 6002450 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization