BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 9886091 · Received March 26, 2020

    Report

    Report Number
    3009862700-2020-00381
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    February 22, 2020
    Report Date
    February 25, 2020
    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 TRANSMITTER AND SENSOR WERE INVESTIGATED, AND CUSTOMER COMPLAINT WAS CONFIRMED VIA DMS. LAB TESTING DID NOT IDENTIFY ANY PERFORMANCE ISSUE WITH TRANSMITTER AND SENSOR. AS INDICATED IN CASE NOTES, THE NEW SENSOR WAS INSERTED WITHIN 3 MM OF OLD SENSOR. LOG FILE ANALYSIS INDICATE THAT TRANSMITTER FIRST CORRECTLY PROGRAMMED SENSOR SERIAL NUMBER (B)(6) WITH SENSOR INSERTION DATE OF 14TH FEB, 2020. HOWEVER ON 22ND FEB, 2020, TRANSMITTER AGAIN TRIED TO PROGRAM INSERTION DATE OF 21ST NOVEMBER, 2019 (WHICH IS PREVIOUS SENSOR'S INSERTION DATE). THIS LIKELY RESULTED IN SENSOR REPLACEMENT ERROR (EC #1) WITH NEW SENSOR SERIAL NUMBER (B)(6) ON DAY 9 POST NEW SENSOR INSERTION.

    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) 2020, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349941 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM QCD SENSEONICS INC. 102096-67A WP06798 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR