BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED QUICK-SET

    MDR report key: 22032820 · Received May 16, 2025

    Report

    Report Number
    3003442380-2025-08956
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    April 18, 2025
    Report Date
    April 19, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244024922
    PMA / PMN Number
    K160648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 2201608- MDR 3003442380-2025-08956- DEVICE 6 OF 8. H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED EIGHT INSULIN FLOW BLOCKED ALARM EVENT (B)(6) 2025. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328796 MINIMED QUICK-SET UNO QUICK-SET 60/9 SC1 2-PACK MUL FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-397AT UNKNOWN 05705244024922

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown