BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 12569084 · Received October 4, 2021

    Report

    Report Number
    3009862700-2021-00117
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    September 7, 2021
    Report Date
    September 7, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SENSOR WAS INVESTIGATED, AND THE ISSUE WAS CONFIRMED DURING BOTH IN-VITRO AND IN-VIVO INVESTIGATION. THE INVESTIGATION SHOWS THAT THE SYSTEM CORRECTLY DISABLED THE SENSOR DUE TO PERFORMANCE FAILURE (LOW OVERALL GLUCOSE SIGNALS LEADING TO MSP) AND THE SYSTEM'S SELF-TEST FUNCTIONS ARE WORKING NORMALLY. MSP FAILURES WERE INVESTIGATED IN (B)(4), WHICH DETERMINED THE ROOT CAUSE OF THESE FAILURES TO BE SENSOR OXIDATION. THIS SENSOR HAS THE SAME FAILURE MODE AND ADDITIONAL INVESTIGATION IS NOT NECESSARY FOR THIS COMPLAINT. AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED TO OFFER THE USER A SENSOR REPLACEMENT.

    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
    1470814 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102096-67A WP08273 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female