BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSET GUARD

    MDR report key: 25024484 · Received April 29, 2026

    Report

    Report Number
    8021545-2026-05224
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 2, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018877
    PMA / PMN Number
    K173879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: SPAIN. NAME: MEDTRONIC MINIMED, COUNTRY: UNITED STATES OF AMERICA, STREET: 18000 DEVONSHIRE STREET, CITY: NORTHRIDGE, STATE: CA, ZIP CODE: 91325 ¿ 1219. 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: 802154, MANUFACTURING SITE: 8021545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT FACED INFUSION SET TAPE NOT STICKING EVENT ON (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33850 INSET GUARD SET, ADMINISTRATION, INTRAVASCULAR FPA UNOMEDICAL A/S MMT-242A 6012014 05705244018877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown