BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 12630459 · Received October 14, 2021

    Report

    Report Number
    3009862700-2021-00128
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 14, 2021
    Report Date
    September 14, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022349
    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

    NO FURTHER INFORMATION WAS RECEIVED FROM THE USER DESPITE MAKING SEVERAL FOLLOW UP ATTEMPTS. NO FURTHER INVESTIGATION WAS FOUND NECESSARY. REMOVAL STATUS CANNOT BE CONFIRMED DUE TO NON-RESPONSE FROM THE USER. D4. DEVICE INFORMATION WAS UPDATED. H4. DEVICE MANUFACTURER DATE WAS UPDATED TO 17 MARCH 2021.

    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 14TH 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
    1534235 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102096-67A WP08435 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male