BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 11758503 · Received May 1, 2021

    Report

    Report Number
    3009862700-2021-00067
    Event Type
    Injury
    Date Received
    May 1, 2021
    Date of Event
    February 2, 2021
    Report Date
    April 1, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491021441
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE ANALYSIS, IT COULD NOT BE CONFIRMED IF THERE WAS ANY SYSTEM MALFUNCTION AS THE DATE AND TIME OF THE REPORTED EVENT WAS NOT SHARED. PER THE DMS DATA BETWEEN (B)(6)AND (B)(6) AS THE ARBITRARY DATE, IT COULD NOT BE CONFIRMED IF THERE WAS ANY TEMPORARY SENSOR INACCURACY AT THE TIME. SINCE THE MARD FOR 1 WEEK LEADING UP TO THE REPORTED EVENT WAS 5.38%, IT WAS OBSERVED THE SENSOR READINGS MATCHED THE FINGERSTICK CALIBRATIONS. H6: INVESTIGATION FINDINGS UPDATED TO 213. H6: INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    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 ADVERSE EVENT WHERE USER EXPERIENCED COUPLE OF HYPOGLYCEMIC EPISODES DUE TO INACCURACIES IN SENSOR READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654831 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102208-500 117537 00817491021441

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR