BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE TRANSMITTER

    MDR report key: 18117356 · Received November 12, 2023

    Report

    Report Number
    3009862700-2023-00292
    Event Type
    Injury
    Date Received
    November 12, 2023
    Date of Event
    August 10, 2023
    Report Date
    November 12, 2023
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491023445
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF INTERNAL REVIEW. THE USER COMPLAINED OF DISCREPANT MEASUREMENTS BETWEEN CAPILLARY AND SENSOR WHERE THE BG WAS AT 48 MG/DL AND THE SG READ 129 MG/DL ON (B)(6) 2023, 11:16 PM. A REVIEW OF THE GLUCOSE TREND DATA ON (B)(6) 2023 CONFIRMED THE EVENT DESCRIBED IN THE COMPLAINT, WHERE THE SENSOR RECORDED A GLUCOSE CONCENTRATION OF 129 MG/DL WHILE THE USER MEASURED A BG OF 48 MG/DL AT (B)(6) 2023, 11:16 PM. THIS CALIBRATION WAS MARKED AS A SUSPICIOUS FINGERSTICK. IN ASSOCIATED S4 CASE #(B)(4), CREATED TO DOCUMENT SENSOR INACCURACIES, IT WAS DETERMINED THAT THE SYSTEM OBSERVED A TEMPORARY PERIOD OF VARIABILITY, MOST LIKELY DUE TO EARLY WEAR ADJUSTMENT. IT WAS ALSO OBSERVED THAT SOME CALIBRATIONS WERE ENTERED AFTER GAPS IN DATA, AND IT WAS RECOMMENDED THAT THE USER MAY EXPERIENCE LESS LAG BY ALLOWING THE SYSTEM TO DISPLAY 1-2 SG READINGS AFTER A GAP BEFORE ENTERING A CALIBRATION. THE OVERALL SENSOR PERFORMANCE WAS EVALUATED AFTER THE EVENT, AND THE SENSOR IS PERFORMING WITH EXPECTATIONS. THE USER IS CURRENTLY USING THE SYSTEM WITH NO FURTHER INACCURACY COMPLAINTS.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE CUSTOMER HAD A HYPOGLYCEMIA EVENT ON (B)(6) 2023 AT 11:16 PM. THE MEASURED BLOOD GLUCOSE (BG) VALUE WAS 48 MG/DL WHERE THE SENSOR GLUCOSE (SG) READING WAS 129 MG/DL. THE EVERSENSE CGM SYSTEM DID NOT ASSERT ANY ALERTS SINCE THE SG VALUE WAS WITHIN NORMAL GLUCOSE RANGE. THE CUSTOMER DID NOT REQUIRE ANY MEDICAL ATTENTION AND WAS ABLE TO SELF RESOLVE. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228322 EVERSENSE TRANSMITTER EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM QHJ SENSEONICS INC. 102208-906 132066 00817491023445

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other