BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 11803823 · Received May 10, 2021

    Report

    Report Number
    3009862700-2021-00073
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022523
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RMA WAS AUTHORIZED BUT NOT RECEIVED SO NO FURTHER CONFIRMATION OR INVESTIGATION OF THE COMPLAINT IS POSSIBLE. AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED TO OFFER THE USER A SENSOR REPLACEMENT. 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 RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699236 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102812-67A WP07766 00817491022523

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR