BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 12030218 · Received June 20, 2021

    Report

    Report Number
    3009862700-2021-00083
    Event Type
    Injury
    Date Received
    June 20, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 21, 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

    PER CASE NOTES, THE SENSOR WAS REMOVED (B)(6) 2021. NO FURTHER INVESTIGATION WAS FOUND NECESSARY. D2. PRODUCT CODE UPDATED TO QHJ. D6B. EXPLANTED (B)(6) 2021. 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 MAY 21ST 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
    926881 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07834 00817491022349
    926882 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP07834 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male