BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 13423413 · Received February 2, 2022

    Report

    Report Number
    3009862700-2022-00022
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 21, 2022
    Report Date
    January 21, 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

    PER INITIAL ESCALATION ANALYSIS, THE SENSOR WAS IN ITS EARLY USAGE. AT THE TIME, THE SENSOR WAS SETTLING WHEN THE USER REPORTED MISMATCH BETWEEN THE SENSOR READINGS AND FINGERSTICK MEASUREMENTS. THIS BEHAVIOR MAY BE DUE TO LACK OF HYDRATION OF THE SENSOR AFTER INSERTION. THE RMA WAS AUTHORIZED DUE TO CUSTOMER EXPERIENCE. UPON RECEIPT OF THE RMA, THE SENSOR WAS TESTED IN-HOUSE, AND THE REVIEW OF QC DID NOT REVEAL ANY MALFUNCTION OF THE SENSOR. AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED TO OFFER THE USER A SENSOR REPLACEMENT. D2. PRODUCT CODE UPDATED TO QHJ. D9. DEVICE AVAILABLE FOR EVALUATION? YES 02 FEBRUARY 2022. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 213, 3221. H6. INVESTIGATION CONCLUSIONS UPDATED TO 67. ,

    Description of Event or Problem · 0

    ON 21 JANUARY 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
    258355 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP08507 00817491022349
    741303 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 102096-67A WP08507 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male