BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 24375004 · Received February 18, 2026

    Report

    Report Number
    8021545-2026-00312
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 6, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT CITY: (B)(6); PATIENT COUNTRY: SWITZERLAND. 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 PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TREND PICKED UP, THIS WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SWITZERLAND. IT WAS REPORTED THAT THE PATIENT FACED INSULIN ACCUMULATING UNDER THE SKIN ON (B)(6) 2026. PATIENT BLOOD GLUCOSE ROSE TO APPROX 180-198 MG/DL. LOCATION OF ISSUE IS ABDOMEN. PATIENT EXPERIENCED SKIN IRRITATION/PAIN/INFECTION. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435135 INSET GUARD UNO EWIS BLUE 60/6 HCAP 10PK INT FPA UNOMEDICAL A/S MMT-431A UNKNOWN 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown