BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 12729604 · Received November 1, 2021

    Report

    Report Number
    3009862700-2021-00133
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    September 29, 2021
    Report Date
    October 1, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    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. REVIEW OF IN-VIVO DATA THROUGH DMS SHOWS THAT EC#30 (LED DISCONNECT ERROR) WAS TRIGGERED ON 1ST OCTOBER 2021. HOWEVER, IN-VITRO QC TEST DID NOT FIND ANY PERFORMANCE ISSUE WITH THE SENSOR, AND SENSOR MANAGER SOFTWARE MEASUREMENTS OF THE SENSOR SHOWED THAT THE LED FLAG FOR SENSOR (B)(6) CLEARED AT FIELD CURRENT THRESHOLD EVEN LOWER THAN 412 ADC COUNTS. THE ROOT CAUSE FOR THE REPORTED IN-VIVO EC#30 (LED DISCONNECT) IS THEREFORE UNCLEAR. 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
    1625871 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102620-67A WP08435

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female