BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 14466315 · Received May 21, 2022

    Report

    Report Number
    3009862700-2022-00091
    Event Type
    Injury
    Date Received
    May 21, 2022
    Date of Event
    January 24, 2021
    Report Date
    March 18, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS. PER CASE NOTES, THE USER WHO IS A SUBJECT OF THE POST APPROVAL STUDY (PAS) WAS ADMITTED TO THE EMERGENCY ROOM (ER) FOR ABDOMINAL PAIN WITH SYMPTOMS OF GASTRITIS AND CONSTIPATION. USER'S GLUCOSE VALUE WAS MEASURED TO BE 518 MG/DL AND WAS ADMINISTERED WITH INSULIN. SINCE, THE USER WAS NOT WEARING THE DEVICE AT THE TIME OF THE ADVERSE EVENT, THE SYSTEM WOULDN'T HAVE TRIGGERED ANY ALERTS. NO FURTHER INVESTIGATION WAS FOUND NECESSARY FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    ON (B)(6) 2021, SENSEONICS WAS MAE AWARE OF AN EVENT WHERE THE USER WAS ADMITTED TO THE ER FOR ABDOMINAL PAIN WITH SYMPTOMS OF GASTRITIS AND CONSTIPATION WITH A GLUCOSE VALUE OF 518 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563687 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Hospitalization