BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 23288200 · Received October 15, 2025

    Report

    Report Number
    3003442380-2025-14988
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    March 30, 2025
    Report Date
    September 19, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244017337
    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: UNITED STATES. SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS ON REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) FOR LESS THAN 24 HOURS DUE TO INSULIN FLOW BLOCK. UPON ADMISSION, THE PATIENT PRESENTED WITH SEVERELY ELEVATED BLOOD GLUCOSE LEVELS RANGING BETWEEN 800-900 MG/DL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS (DKA) ACCORDING TO HOSPITAL RECORDS. DURING THE HOSPITAL STAY, INSULIN WAS ADMINISTERED VIA INTRAVENOUS (IV) DRIP. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2646861 QUICK SET UNO QUICK-SET 46/6 SC1 MECA FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-394A UNKNOWN 05705244017337

    Patients

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