BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 20595459 · Received November 3, 2024

    Report

    Report Number
    3009862700-2024-01033
    Event Type
    Injury
    Date Received
    November 3, 2024
    Date of Event
    September 30, 2024
    Report Date
    January 15, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    UDI-DI
    00817491024282
    PMA / PMN Number
    P160048
    Adverse Event
    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

    D2B.PRODUCT CODE CORRECTED TO SBA.

    Additional Manufacturer Narrative · 0

    THE USER REPORTED AN EVENT WHERE THE SYSTEM TRIGGERED A FALSE LOW GLUCOSE ALERT WHEN THE BG WAS IN NORMAL RANGE ON (B)(6) 2024 AROUND 05:28 PM. THE USER MENTIONED THAT THE SG AT THE TIME WAS 52 MG/DL WHILE THE BG WAS 80 MG/DL. A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) DATA CONFIRMED THAT THE SG VALUE ON (B)(6) 2024 AT 5:28 PM WAS 62 MG/DL AND BG WAS NOT ENTERED. A REVIEW OF THE ALERT HISTORY REVEALED THAT THE USER RECEIVED A LOW GLUCOSE ALERT AT 5:28 PM. THE USER DID NOT SEEK MEDICAL TREATMENT AS THE BG WAS IN NORMAL RANGE. IN AN ASSOCIATED COMPLAINT OF THE USER ABOUT SENSOR INACCURACY, IT WAS OBSERVED THAT THE SYSTEM WAS HAVING SOME INSTABILITY IN THE SIGNAL AND REFERENCE CHANNELS. THE USER WAS INSERTED ON (B)(6) 2024, AND THE INCIDENT OCCURRED 5 DAYS AFTER INSERTION. IT IS EXPECTED TO SEE SOME DIFFERENCES DURING THE EARLY DAYS AS THE SYSTEM IS STABILIZING WHILE THE INSERTION SITE IS HEALING, AS STATED IN THE USER GUIDE. THE USER WAS ADVISED TO KEEP USING THE SYSTEM AND WAS EDUCATED ABOUT LAG AND EARLY WEAR PERIOD. THE SENSOR IS CURRENTLY IN USE, AND THE SYSTEM IS DISPLAYING GOOD AGREEMENT BETWEEN THE SENSOR READINGS AND CALIBRATION ENTRIES. THE ROOT CAUSE OF THE REPORTED INACCURACY CAN BE ATTRIBUTED TO EARLY WEAR ADJUSTMENT. B4.DATE OF THIS REPORT UPDATED TO (B)(6) 2024. D4.UPDATED ADDITIONAL DEVICE INFORMATION G3 DATE RECEIVED BY THE MANUFACTURER? (B)(6) 2024. H3.DEVICE EVALUATED BY MANUFACTURER? YES. H6. INVESTIGATION FINDINGS UPDATED TO 114. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    Description of Event or Problem · 0

    ON 04 OCTOBER 2024,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER RECEIVED A FALSE HYPOGLYCEMIA ALERT FROM THE SYSTEM DUE TO SENSOR INACCURACY. THE USER REPORTED ON 30 OCTOBER 2024, AROUND 05:28 PM THAT THEIR SG WAS 52 MG/DL AND BG WAS AROUND 80 MG/DL.PER DMS, IT WAS CONFIRMED THAT THE USER RECEIVED A LOW GLUCOSE ALERT AT 05:28 PM, WHEN THE SG WAS AT 52 MG/DL USER DIDN'T SEEK FOR MEDICAL TREATMENT. USER DIDN'T TAKE ANY ACTIONS TO SOLVE THE EVENT BECAUSE HE CONFIRMED THAT IT WAS A FALSE LOW EVENT AND HE HAD NO SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790200 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM SBA SENSEONICS INC. 103606-600 02E264S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other