BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 18998660 · Received March 28, 2024

    Report

    Report Number
    3009862700-2024-00512
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    September 28, 2023
    Report Date
    March 28, 2024
    Manufacturer
    SENSEONICS, INCORPORATED
    Product Code
    QHJ
    UDI-DI
    00817491023308
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF INTERNAL REVIEW. THE RETURNED SENSOR WAS TESTED IN-HOUSE, HOWEVER, THE TESTING RESULTS DID NOT INDICATE ANY MALFUNCTION OF THE SENSOR. THE FAILURE MODE (SENSOR PERFORMANCE DEVIATION) COULD NOT BE REPRODUCED DURING THE RETURNED PRODUCT ANALYSIS TESTING. 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 SUCH 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 WHICH IS NOT REPRODUCED IN THE LAB. AS PART OF RESOLUTION, A RETURN MATERIAL AUTHORIZATION WAS ISSUED FOR SENSOR REPLACEMENT. NO FURTHER RESOLUTION WAS NECESSARY FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    ON SEP. 28, 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
    2060282 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS, INCORPORATED 101967-950 WP09146 00817491023308

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other