BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21923484 · Received April 28, 2025

    Report

    Report Number
    3009862700-2025-00660
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    January 28, 2025
    Report Date
    April 28, 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

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF INTERNAL REVIEW.THE USER REPORTED A COMPLAINT REGARDING INACCURATE SENSOR READINGS. UPON REVIEW OF THE SYSTEM DATA AND PROVIDED EXAMPLES, IT WAS OBSERVED THAT THE SYSTEM EXHIBITED GREATER VARIABILITY THAN TYPICAL, ALONG WITH DIFFERENCES ATTRIBUTABLE TO THE EXPECTED DELAY (LAG) BETWEEN CHANGES IN BLOOD GLUCOSE (BG) AND CORRESPONDING SENSOR GLUCOSE (SG) READINGS. THE USER WAS ADVISED TO CONTINUE USING THE SYSTEM WITH CALIBRATION WHILE THE ESCALATION TEAM CONTINUED TO MONITOR SYSTEM PERFORMANCE. DURING A FOLLOW-UP, IT WAS CONFIRMED THAT THE SYSTEM WAS PERFORMING WITHIN EXPECTED PARAMETERS. OVERALL, BG VALUES ALIGNED WELL WITH SG TRENDS, TAKING INTO ACCOUNT THE INHERENT DELAY COMMON TO CGM SYSTEMS. THE USER WAS PROVIDED WITH RECOMMENDATIONS ON PROPER CALIBRATION TECHNIQUES, ACKNOWLEDGED THE INFORMATION, AND NO FURTHER ACTION WAS REQUIRED.

    Description of Event or Problem · 0

    ON 28 JAN 2025, SENSONICS WAS MADE AWARE OF AN INCIDENT IN WHICH A USER REPORTED SENSOR INACCURACIES WHILE USING THE SYSTEM.THE CASE WAS ESCALATED TO NEXT LEVEL SUPPORT FOR FURTHER ASSISTANCE. THE USER PROVIDED THE FOLLOWING EXAMPLES: ON (B)(6) 2025 AT 01:03 PM, USER'S SG WAS 217 MG/DL AND BG WAS 197 MG/DL. ON (B)(6) 2025 AT 01:32 PM, USER'S SG WAS 187 MG/DL AND BG WAS 202 MG/DL. ON (B)(6) 2025 AT 10:33 AM, USER'S SG WAS 109 MG/DL AND BG WAS 126 MG/DL. ON (B)(6) 2025 AT 01:04 AM, USER'S SG WAS 78 MG/DL AND BG WAS 120 MG/DL. THE CASE WAS ESCALATED TO NEXT LEVEL SUPPORT FOR FURTHER ASSISTANCE.NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. BASED ON OUR REVIEW OF THE SYSTEM AND EXAMPLES, WE CAN SEE THAT THE SYSTEM WAS SHOWING MORE VARIABILITY THAN IS TYPICAL AND SOME DIFFERENCES DUE TO THE DELAY (LAG) THAT OFTEN OCCURS BETWEEN CHANGES IN BG VALUES AND THE CORRESPONDING CHANGE IN SENSOR READINGS, TYPICAL OF CGM SYSTEMS. NEXT-LEVEL SUPPORT ADVISED THE USER TO ALLOW THE SYSTEM A FEW MORE DAYS TO ADJUST AND TO ENTER ADDITIONAL CALIBRATIONS AS PROMPTED. AN ADDITIONAL REVIEW OF AVAILABLE DATA SHOWS THAT BG VALUES ENTERED AS CALIBRATIONS CONTINUE TO FIT GLUCOSE TRENDS WELL. DIFFERENCES OBSERVED CAN BE EXPLAINED BY LAG AND A SLIGHT ADJUSTMENT OF THE SYSTEM BASED ON CALIBRATION VALUES ENTERED. ON 31 JANUARY 2025, THE USER CONTACTED SUPPORT AGAIN, WAS NOT QUITE SATISFIED WITH THE EXPLANATION PROVIDED AND PROVIDED THE BELOW EXAMPLE SETS: ON (B)(6) 2025 AT 12:09 PM USER'S BG WAS 106 MG/DL AND SG WAS121 MG/DL. ON (B)(6) 2025 AT 01:25 PM USER'S BG WAS 180 MG/DL AND SG WAS166 MG/DL. THE CASE HAS BEEN RE-ESCALATED TO NEXT-LEVEL SUPPORT FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1290563 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 01E275S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female