BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-PORT ADVANCE

    MDR report key: 22910246 · Received August 28, 2025

    Report

    Report Number
    3003442380-2025-13281
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 6, 2025
    Report Date
    August 7, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244009394
    PMA / PMN Number
    K120337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: KOREA, REPUBLIC OF. 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 KOREA, REPUBLIC OF. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE LEAKAGE WAS AT THE BODY OF DEVICE. THE BLOOD GLUCOSE LEVEL WAS 248 MG/DL AND THE PATIENT WAS TREATED WITH INSULIN. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520038 I-PORT ADVANCE I-PORT ADVANCE 6 MM FPA UNOMEDICAL DEVICES S.A. DE C.V. MMT-100 UNKNOWN 05705244009394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown