BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 20675259 · Received November 13, 2024

    Report

    Report Number
    3009862700-2024-01064
    Event Type
    Injury
    Date Received
    November 13, 2024
    Date of Event
    October 12, 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

    THE USER REPORTED EXPERIENCING HYPERGLYCEMIC EVENT ON 12-OCT-2024. THE USER MENTIONED THAT THE BG AT THE TIME WAS 56 MG/DL AND SG WAS 118 MG/DL. A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) DATA REVEALED THAT THE SG VALUE ON (B)(6) 2024 AT 4:08 PM WAS 118 MG/DL AND MANUAL ENTRY BG AT 4:13 PM WAS 56 MG/DL. A REVIEW OF THE ALERT HISTORY REVEALED THAT THE USER RECEIVED A PREDICTED LOW GLUCOSE ALERT AT 4:13 PM AND RATE FALLING ALERT AT 4:18 PM. THE USER DID NOT SEEK MEDICAL TREATMENT AND RESOLVED THE EVENT BY DRINKING JUICE. IN AN ASSOCIATED CASE FOR THE USER'S COMPLAINT ABOUT SENSOR INACCURACY (COMPLAINT: (B)(4), AN OVERALL REVIEW OF THE SYSTEM AROUND THE EVENT DATE WAS PERFORMED, AND THE SG AND BG VALUES WERE IN GOOD AGREEMENT WITH SOME OCCASIONAL DIFFERENCES DUE TO LAG POTENTIALLY CAUSED BY CALIBRATIONS ENTERED DURING PERIODS OF RAPID CHANGE IN GLUCOSE. THE USER WAS ADVISED TO CONTINUE USING THE SYSTEM ENTERING CALIBRATIONS WHEN THE GLUCOSE IS STABLE. THE USER WAS SATISFIED WITH THE INFORMATION GIVEN. THE SENSOR IS CURRENTLY IN USE, AND THE SYSTEM IS DISPLAYING GOOD AGREEMENT BETWEEN THE SENSOR READINGS AND CALIBRATION ENTRIES. B4. DATE OF THIS REPORT 27 NOVEMBER 2024. G3. DATE RECEIVED BY THE MANUFACTURER? 26 NOVEMBER 2024. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. INVESTIGATION FINDINGS UPDATED TO 114. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    Additional Manufacturer Narrative · 0

    D2B.PRODUCT CODE CORRECTED TO SBA.

    Description of Event or Problem · 0

    ON 14TH OCTOBER 2024,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT ON 12 OCTOBER 2024,THEIR SG WAS 118 MG/DL AND BG WAS 56 MG/DL.PER DMS, THE SG AND BG VALUES WERE CONFIRMED AND USER RECEIVED A PREDICTIVE LOW ALERT AT 04:13 PM, WHEN THE SG WAS AT 56 MG/DLUSER RESOLVED THE EVENT BY DRINKING JUICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306997 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM SBA SENSEONICS INC. 103606-600 02E264S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other