BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 13290508 · Received January 19, 2022

    Report

    Report Number
    3009862700-2022-00010
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Date of Event
    December 21, 2021
    Report Date
    December 21, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    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

    BASED ON THE INITIAL ESCALATION ANALYSIS, IT WAS OBSERVED THAT THE SENSOR READINGS CLOSELY MATCHED WITH THE FINGERSTICK MEASUREMENTS WITH OCCASIONAL MISMATCH. THE OVERALL SENSOR PERFORMANCE WAS WITHIN EXPECTATION AT THE TIME OF THE ANALYSIS. THE RMA WAS AUTHORIZED DUE TO CUSTOMER EXPERIENCE. UPON RECEIVING OF THE RMA IN-HOUSE, IT WAS FOUND THAT THE SENSOR WAS UNRESPONSIVE, MEANING THAT THE SENSOR MAY HAVE GOTTEN DAMAGED DURING REMOVAL. NO FURTHER INVESTIGATION COULD BE DONE AT THIS TIME. AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED TO OFFER THE USER A SENSOR REPLACEMENT. D9: DEVICE AVAILABLE FOR EVALUATION? YES, 15 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.

    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) 2021, 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
    635844 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102096-67A WP08435 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male