BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 12615321 · Received October 12, 2021

    Report

    Report Number
    3009862700-2021-00125
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    September 10, 2021
    Report Date
    September 10, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE USER THE REMOVAL STATUS OF THE SENSOR COULD NOT BE CONFIRMED. D2. PRODUCT CODE CHANGED TO QHJ.

    Additional Manufacturer Narrative · 1

    THIS MDR IS RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS. THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON 10TH SEPTEMBER 2021,SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510077 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC.
    1510083 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male