BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21500847 · Received March 1, 2025

    Report

    Report Number
    3009862700-2025-00217
    Event Type
    Malfunction
    Date Received
    March 1, 2025
    Date of Event
    January 30, 2025
    Report Date
    March 1, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    UDI-DI
    00817491024282
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON AN ADDITIONAL REVIEW OF THE SYSTEM, BG VALUES ENTERED AS CALIBRATIONS FIT SG TRENDS WELL WITH OCCASIONAL DIFFERENCES DUE TO LAG THE PAST 30 DAYS. UPON REVIEW OF THE EXAMPLES PROVIDED BY THE USER, WE NOTICED THAT BG VALUES PROVIDED WERE NOT ENTERED IN THE SYSTEM. WE SUGGEST THAT THE USER ENTERS ALL BG VALUES INTO THE SYSTEM, AS CALIBRATIONS OR GLUCOSE EVENTS, WHEN DIFFERENCES ARE OBSERVED. THIS MAY HELP THE SYSTEM ADJUST BASED ON THE INFORMATION ENTERED AS A CALIBRATION AND WILL ASSIST US IN EVALUATING THE USER'S CONCERNS. DURING OUR REVIEW WE OBSERVED THAT SOME CALIBRATIONS WERE ENTERED AFTER GAPS IN DATA. THE USER MAY EXPERIENCE LESS LAG BY ALLOWING THE SYSTEM TO DISPLAY 1-2 SG READINGS AFTER A GAP BEFORE ENTERING A CALIBRATION.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WERE REPORTED INACCURACY IN SENSOR READINGS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697071 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 02E347S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown