BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 11754302 · Received April 30, 2021

    Report

    Report Number
    3009862700-2021-00066
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 1, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022349
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RMA WAS AUTHORIZED BUT NOT RECEIVED SO NO FURTHER CONFIRMATION OR INVESTIGATION OF THE COMPLAINT IS POSSIBLE. NO RESOLUTION WAS POSSIBLE SINCE THE USER WAS NOT REACHABLE DESPITE OF MAKING MULTIPLE ATTEMPTS. HCP INFORMATION COULD NOT BE CONFIRMED, THUS NO RMA COULD BE SUCCESSFULLY PROCESSED. H3. DEVICE EVALUATED BY MANUFACTURER? NO, NOT RETURNED TO MANUFACTURERH6. TYPE OF INVESTIGATION UPDATED TO 4114.H6. INVESTIGATION FINDINGS UPDATED TO 3221.H6. INVESTIGATION CONCLUSIONS UPDATED TO 67.

    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 01ST 2021, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649735 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102096-67A WP07834 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR