BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 14086503 · Received April 12, 2022

    Report

    Report Number
    3009862700-2022-00057
    Event Type
    Injury
    Date Received
    April 12, 2022
    Date of Event
    March 18, 2022
    Report Date
    March 18, 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, THERE WAS TEMPORARY MISMATCH BETWEEN THE SENSOR READINGS AND THE FINGERSTICK MEASUREMENT. THE HYPO ALERT WAS ASSERTED PRIOR TO THE EVENT. EVEN THOUGH THE SYSTEM WAS NOT WITHIN THE 20/20 ERROR TARGET OF THE SYSTEM, THIS WAS NOT DUE TO A SYSTEM FAILURE, AND IT WAS WITHIN THE 30/30 ERROR BOUNDS OF THE CGM SYSTEM. THIS OCCASIONAL OCCURRENCE IS STILL CONSISTENT WITH NORMAL SYSTEM OPERATION. AFTER THE EVENT, THE SYSTEM DISPLAYED BETTER AGREEMENT BETWEEN THE SENSOR READINGS AND FINGERSTICK MEASUREMENTS. PER CASE NOTES, USER DID NOT HAVE ANY SYMPTOMS, DID NOT REQUIRE MEDICAL OR SELF TREATMENT. AFTER THE EVENT, THE SYSTEM DISPLAYED BETTER AGREEMENT BETWEEN THE SENSOR READINGS AND FINGERSTICK MEASUREMENTS. 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 18 MARCH 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
    190480 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102208-500 122612 00817491021441

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male