BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 19006856 · Received March 29, 2024

    Report

    Report Number
    3009862700-2024-00525
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    October 19, 2023
    Report Date
    March 29, 2024
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491023681
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF AN INTERNAL REVIEW. THE REVIEW OF THE GLUCOSE PLOT SHOWS TWO CONSECUTIVE DROP OUT PHASES WITHIN 14 DAYS THAT TRIGGERED THE SENSOR REPLACEMENT ALERT ON (B)(6) 2023. THE RETURNED SENSOR WAS TESTED IN-HOUSE, HOWEVER, AND THE FAILURE MODE COULD NOT BE REPRODUCED. THIS MAY OCCUR IN SOME INSTANCES WHERE THE FAILURE MODE THAT PRESENTS ITSELF IN THE BODY IS NOT REPRODUCED IN THE LAB. THE POTENTIAL ROOT CAUSE FOR THE REPORTED FAILURE MODE MAY BE RELATED TO AN ISSUE WITH THE SENSOR ELECTRONICS, FOR EXAMPLE THE LED BEHAVIOR AT THE TIME, OR THE IN VIVO STATE OF THE SENSOR HYDROGEL. AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED FOR SENSOR REPLACEMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2586870 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 101967-931 WP09237 00817491023681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown