BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 14269045 · Received May 3, 2022

    Report

    Report Number
    3009862700-2022-00065
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 4, 2022
    Report Date
    April 4, 2022
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491022523
    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

    D2: PRODUCT CODE CORRECTED TO QHJ.

    Additional Manufacturer Narrative · 0

    THE SENSOR WAS TESTED IN-HOUSE, AND THE REVIEW OF QC REVEALED A LOSS OF CHEMICAL PERFORMANCE, WHICH CONFIRMS THE COMPLAINT. THE INVESTIGATION SHOWS THE SYSTEM CORRECTLY DISABLED THE SENSOR DUE TO PERFORMANCE FAILURE (LOW OVERALL GLUCOSE SIGNALS LEADING TO MSP) AND THE SYSTEM'S SELF-TEST FUNCTIONS ARE WORKING NORMALLY. MSP FAILURES WERE INVESTIGATED IN (B)(4), WHICH DETERMINED THE ROOT CAUSE OF THESE FAILURES TO BE SENSOR'S HYDROGEL OXIDATION. THIS SENSOR HAS THE SAME FAILURE MODE AND ADDITIONAL INVESTIGATION IS NOT NECESSARY FOR THIS COMPLAINT. AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED TO OFFER THE USER A SENSOR REPLACEMENT. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. INVESTIGATION FINDINGS UPDATED TO 3231. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4307.

    Description of Event or Problem · 0

    ON 04 FEBRUARY 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749619 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102812-67A WP08497 00817491022523

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male