BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 24997078 · Received April 27, 2026

    Report

    Report Number
    8021545-2026-04839
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    March 28, 2026
    Report Date
    April 1, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022683
    PMA / PMN Number
    K210544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: EVENT CITY: (B)(6). EVENT COUNTRY: IRELAND. NAME: MEDTRONIC MINIMED. COUNTRY: UNITED STATES OF AMERICA. STREET: (B)(6). CITY: (B)(6). STATE: (B)(6). ZIP CODE: (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 8021545, MANUFACTURING SITE: 8021545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET TAPE NOT STICKING ISSUE ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153835 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-431A 6015796 05705244022683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown