BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 13485635 · Received February 8, 2022

    Report

    Report Number
    3009862700-2022-00024
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 13, 2022
    Report Date
    January 24, 2022
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491022349
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE USER. THE REMOVAL STATUS OF THE SENSOR COULD NOT BE CONFIRMED. D2: PRODUCT CODE CHANGED TO QHJ.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PHYSICIAN WAS UNABLE TO REMOVE USERS SENSOR ON THE FIRST ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776023 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07603 00817491022349
    431196 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07603 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Other