BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 11788522 · Received May 7, 2021

    Report

    Report Number
    3009862700-2021-00070
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    February 10, 2021
    Report Date
    April 7, 2021
    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. NO FURTHER INVESTIGATION WAS FOUND NECESSARY. D2. PRODUCT CODE UPDATED TO QHJ. H6. INVESTIGATION FINDINGS UPDATED TO 3221. H6. INVESTIGATION CONCLUSIONS UPDATED 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 APRIL 07TH 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
    690225 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07612 00817491022349
    690226 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07612 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female