BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 18754617 · Received February 21, 2024

    Report

    Report Number
    3009862700-2024-00334
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    March 26, 2022
    Report Date
    February 21, 2024
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491023360
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY AS PART OF AN INTERNAL REVIEW. SENSOR WAS REQUESTED TO BE RETURNED FOR EVALUATION. BUT THE PRODUCT WAS NEVER RECEIVED. THUS, NO INVESTIGATION OR CONFIRMATION OF THE COMPLAINT WAS POSSIBLE.

    Description of Event or Problem · 0

    ON MARCH 28, 2022, SENSEONICS WAS MADE AWARE OF A HYPERGLYCEMIA EVENT AND COMPLAINED OF SENSOR INACCURACIES. USER REPORTED THAT THE EVENT HAPPENED ON 26 MARCH 2022 AND PROVIDED THE BELOW EXAMPLES. A. (B)(6) 2022 06:46 PM CET / SG OUT OF RANGE - BG 440 MG/DL. B. (B)(6) 2022 06:58 PM CET / SG OUT OF RANGE - BG 440 MG/DL. USER WASN'T SYMPTOMATIC, DIDN'T SEEK FOR MEDICAL TREATMENT AND RESOLVED THE EVENT BY HAVING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416050 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 101967-750 WP08438 00817491023360

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other