BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 10624484 · Received October 3, 2020

    Report

    Report Number
    3009862700-2020-00506
    Event Type
    Injury
    Date Received
    October 3, 2020
    Date of Event
    September 2, 2020
    Report Date
    September 4, 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

    PER CASE NOTES, THE SENSOR WAS SUCCESSFULLY REMOVED 21 OCTOBER 2020. 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 SEPT 04TH 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
    1089038 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07462 00817491022349
    1089039 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07462 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female