BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 13122479 · Received December 30, 2021

    Report

    Report Number
    3009862700-2021-00159
    Event Type
    Injury
    Date Received
    December 30, 2021
    Date of Event
    November 29, 2021
    Report Date
    November 30, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022349
    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 THAT DUE TO THE INFECTION AT INSERTION SITE THE SENSOR FELL OUT OF THE ARM. THE POSSIBLE ROOT CAUSE FOR THE SENSOR FELL OUT OF THE ARM COULD BE INFECTION. USER SEEMS TO BE DOING FINE.

    Description of Event or Problem · 0

    ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED THAT DUE TO THE INFECTION AT INSERTION SITE THE SENSOR FELL OUT OF THE ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019062 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102096-67A WP08503 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male