BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 10731667 · Received October 24, 2020

    Report

    Report Number
    3009862700-2020-00533
    Event Type
    Injury
    Date Received
    October 24, 2020
    Date of Event
    September 23, 2020
    Report Date
    September 25, 2020
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    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

    DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE USER THE REMOVAL STATUS OF THE SENSOR COULD NOT BE CONFIRMED. D2. PRODUCT CODE CHANGED TO QHJ. H6. INVESTIGATION FINDINGS CHANGED TO 3221 H6. INVESTIGATION CONCLUSIONS CHANGED TO 4311.

    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 SEPTEMBER 25TH 2020, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR IN THE FIRST ATTEMPT MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196497 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07468 00817491022349
    1196498 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07468 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male