BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 14305943 · Received May 6, 2022

    Report

    Report Number
    3009862700-2022-00069
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 15, 2022
    Report Date
    April 16, 2022
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491021441
    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

    THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION ANALYSIS, THE EVENT WAS REPORTED ON THE 2ND DAY AFTER INSERTION ON (B)(6), 2022. THE SENSOR WAS SETTLING AFTER INSERTION AND DISPLAYED TEMPORARY MISMATCH ON (B)(6), 2022. ONCE THE SENSOR SETTLED, THE SYSTEM DISPLAYED BETTER AGREEMENT BETWEEN SENSOR READINGS AND FINGERSTICK MEASUREMENTS (PLEASE REFER TO THE ATTACHED SCREENSHOTS WHICH CAPTURES THE 2 WEEKS OF GLUCOSE PLOT AFTER INSERTION SHOWING THE MARD IS AROUND 13.23%). NOTE: THE HYPO ALERT THRESHOLD WAS SET AT 90 MG/DL, SO THE HYPO ALERTS WERE ASSERTED MORE OFTEN, IF THE SENSOR READINGS WERE BELOW 90 MG/DL. PER THE ANALYSIS, THE FINGERSTICK MEASUREMENTS WERE NOT ENTERED DURING THE REPORTED EVENTS AS CAPTURED IN THE FOLLOW-UP NOTES - A. (B)(6) 2022 7:03 PM CT / SG 84 MG/DL - NO BG VALUE ENTERED. B. (B)(6) 2022 3:38 PM CT / SG 88 MG/DL - NO BG VALUE ENTERED. C. (B)(6) 2022 1:41 PM CT / SG 76 MG/DL - NO BG VALUE ENTERED. THE OVERALL SENSOR PERFORMANCE WAS WITHIN EXPECTATIONS AND THE SYSTEM IS DISPLAYING BETTER ACCURACY (AT THE TIME OF THE ANALYSIS), WHERE THE MARD IS AT 9.92% FOR THE GLUCOSE PLOT BETWEEN (B)(6), 2022 (REFER TO THE ATTACHED SCREENSHOT). USER WASN'T SYMPTOMATIC, DIDN'T SEEK FOR MEDICAL TREATMENT AND RESOLVED THE EVENT ON HER OWN. USER WAS ADVISED TO LET HCP KNOW OF THESE KIND OF EVENTS. USER IS CURRENTLY USING THE SYSTEM WITH UP TO DATE GLUCOSE INFORMATION. NO FURTHER RESOLUTION WAS FOUND NECESSARY FOR THIS COMPLAINT. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. INVESTIGATION FINDINGS UPDATED TO 213. H6. INVESTIGATION CONCLUSIONS UPDATED TO 67.

    Description of Event or Problem · 0

    ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437941 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102208-500 122946 00817491021441

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female