BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 11682168 · Received April 16, 2021

    Report

    Report Number
    3009862700-2021-00063
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 19, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022349
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INITIAL ESCALATION ANALYSIS, IT WAS OBSERVED THAT IT WAS TAKING THE SENSOR A LITTLE OF BIT OF MORE TIME TO RECOVER AFTER INSERTION BUT DUE TO CUSTOMER EXPERIENCE THE RMA WAS AUTHORIZED. THE RMA IS NOT RECEIVED AND THEREFORE NO FURTHER INVESTIGATION COULD BE PERFORMED AT THIS TIME. H3. DEVICE EVALUATED BY MANUFACTURER? NO, NOT RETURNED TO MANUFACTURER. H6. TYPE OF INVESTIGATION UPDATED TO 4114. H6. INVESTIGATION FINDINGS UPDATED TO 3221. H6. INVESTIGATION CONCLUSIONS UPDATED TO 67.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED INACCURACIES IN SENSOR READINGS WHICH LEADS TO EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576759 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM, QCD SENSEONICS INC. 102096-67A WP07766 00817491022349

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR