BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 17234824 · Received June 29, 2023

    Report

    Report Number
    3009862700-2023-00140
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 1, 2023
    Report Date
    September 21, 2023
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491022950
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INITIAL ESCALATION ANALYSIS, THE SENSOR DEVIATED FROM NORMAL BEHAVIOR DUE TO A DECLINE IN THE SIGNAL MODULATION. THE SIGNAL MODULATION STARTED TO DECLINE MARCH 4, 2023. UPON RECEIPT OF THE SENSOR, INVESTIGATION WAS PERFORMED WHICH INDICATED THAT THE WAS RECEIVED AND TESTED, ROOT CAUSE OF THE PERFORMANCE FAILURE WAS DUE TO OXIDATION OF THE CHEMICAL COMPONENT OF THE SENSOR. AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED FOR SENSOR REPLACEMENT. B4. DATE OF THIS REPORT UPDATED TO 21 SEP 2023. G3. DATE RECEIVED BY MANUFACTURER UPDATED TO 29 AUG 2023. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 3231, 174. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4307.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE A USER EXPERIENCED SENSOR INACCURACY WHICH LED TO EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278490 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-81A WP08819 00817491022950

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male