BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 13055207 · Received December 21, 2021

    Report

    Report Number
    3009862700-2021-00172
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    September 14, 2021
    Report Date
    September 21, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022523
    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

    H3: DEVICE EVALUATED BY MANUFACTURER, CORRECTED TO YES.

    Additional Manufacturer Narrative · 0

    THIS MDR IS RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AS SENSOR COMMUNICATED THROUGHOUT THE IN-VITRO QC TEST.

    Description of Event or Problem · 0

    ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED NO SENSOR DETECTED ALERT LEADING TO EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952061 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102812-67A WP08306 00817491022523

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female