BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK SET

    MDR report key: 24754383 · Received April 1, 2026

    Report

    Report Number
    3003442380-2026-06515
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 4, 2026
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244017450
    PMA / PMN Number
    K160648
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REQUEST WAS PERFORMED FOR ADDITIONAL INFORMATION INCLUDING LOT NUMBER; HOWEVER, LOT NUMBER WAS NOT PROVIDED. A COMPLAINT INVESTIGATION WAS INITIATED UNDER COMPLAINT INVESTIGATION. UNFORTUNATELY, NO SPECIFIC LOT NUMBER WAS IDENTIFIED, WHICH LIMITS THE ABILITY TO TRACE OR ANALYZE A PARTICULAR ITEM. INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN JAPAN. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA DUE TO A LEAKAGE EVENT ON (B)(6) 2026. THE CANNULA OF THE INFUSION SET WAS SLIGHTLY WET AND THE PATIENT CONTACTED THE HOSPITAL BECAUSE THE BLOOD GLUCOSE LEVEL WAS 300MG/DL. THE PATIENT WAS INSTRUCTED TO REPLACE THE SET AND ADMINISTER A BOLUS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813640 QUICK SET UNO QUICK-SET 60/6 SC1 MECA FPA UNOMEDICAL UM-D MMT-399A UNKNOWN 05705244017450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention