BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 22391625 · Received July 2, 2025

    Report

    Report Number
    3009862700-2025-00815
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    April 15, 2025
    Report Date
    July 2, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER REPORTED BEING HOSPITALIZED ON 3 OCCASIONS FOR DIVERTICULOSIS. EVENT HAPPENED ON APRIL 15TH 2025, MAY 5TH 2025 AND MAY 27TH, 2025. ACCORDING TO THE USER, THEY HAD TO BE HOSPITALIZED DUE TO DIVERTICULOSIS.THE EVENT WAS NOT RELATED TO THE SENSOR INSERTION/REMOVAL NOR RELATED TO DIABETES.AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A LOW GLUCOSE ALERT AT THE TIME OF EVENT BECAUSE THE SG NEVER WENT BELOW THE ALERT LEVEL AS IT WAS UNRELATED TO DIABETES.THE USER SOUGHT FOR MEDICAL TREATMENT, BY GOING TO THE HOSPITAL.

    Description of Event or Problem · 0

    USER REPORTED BEING HOSPITALIZED ON 3 OCCASIONS FOR DIVERTICULOSIS. EVENT HAPPENED ON APRIL 15TH 2025, MAY 5TH 2025 AND MAY 27TH, 2025. ACCORDING TO THE USER, THEY HAD TO BE HOSPITALIZED DUE TO DIVERTICULOSIS.THE EVENT WAS NOT RELATED TO THE SENSOR INSERTION/REMOVAL NOR RELATED TO DIABETES.AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A LOW GLUCOSE ALERT AT THE TIME OF EVENT BECAUSE THE SG NEVER WENT BELOW THE ALERT LEVEL AS IT WAS UNRELATED TO DIABETES.THE USER SOUGHT FOR MEDICAL TREATMENT, BY GOING TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200656 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female Hospitalization