BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 11698534 · Received April 20, 2021

    Report

    Report Number
    3009862700-2021-00060
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 21, 2021
    Report Date
    March 22, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022349
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD NOT BE CONFIRMED DURING IN-HOUSE TESTING, AS THE ISSUE WAS NOT REPRODUCED. HOWEVER, REVIEW OF THE IN-VIVO DATA CONFIRMS THAT THE CUSTOMER RECEIVED SENSOR REPLACEMENT ALERTS EC#1 AND EC#39, AND A REVIEW OF THE GLUCOSE RATE OF CHANGE CONFIRMS THAT THE CAUSE OF THE FAILURE WAS LIKELY NOISE IN THE GLUCOSE VALUES ON (B)(6) 2021. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 4203. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4307.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590378 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102096-67A WP06613 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR