BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 14438989 · Received May 19, 2022

    Report

    Report Number
    3009862700-2022-00078
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 25, 2022
    Report Date
    April 25, 2022
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491022349
    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

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

    Additional Manufacturer Narrative · 0

    BASED ON THE INITIAL ESCALATION ANALYSIS, THE RMA WAS AUTHORIZED AS THE SENSOR PERFORMANCE DEVIATED FROM NORMAL BEHAVIOR. UPON RECEIPT OF THE RMA, IT WAS FOUND THAT THE SENSOR WAS MISSING HYDRO-GEL ON THE FRONT, LIKELY SCRAPED OFF DURING REMOVAL. THE QC DATA COULD THEREFORE NOT HELP DETERMINE THE ROOT CAUSE OF THE REPORTED INACCURACY. AS PART OF RESOLUTION, THE USER RECEIVED A NEW SENSOR. D9 DEVICE AVAILABLE FOR EVALUATION? YES, DEVICE RECEIVED ON 01 JUNE 2022. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 114. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    Description of Event or Problem · 0

    ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED INACCURACIES IN SENSOR READINGS WHICH LEADS TO EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392517 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP08507 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female