BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 13079435 · Received December 23, 2021

    Report

    Report Number
    3009862700-2021-00171
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    November 7, 2021
    Report Date
    November 10, 2021
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    UDI-DI
    00817491022356
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INITIAL ESCALATION ANALYSIS, IT WAS SUGGESTED TO ISSUE AN RMA FOR THE SENSOR 240552 AS THE ROOT CAUSE FOR NOISE IN THE GLUCOSE READINGS COULD NOT BE CONFIRMED. THE RMA WAS AUTHORIZED TO BRING BACK THE SENSOR FOR FURTHER INVESTIGATION.UPON RECEIVING THE RMA, THE SENSOR WAS TESTED IN-HOUSE, AND THE REVIEW OF QC DID NOT REVEAL ANY MALFUNCTION OF THE SENSOR.AS PART OF RESOLUTION, A RMA WAS AUTHORIZED TO OFFER THE USER, A SENSOR REPLACEMENT. H3.DEVICE EVALUATED BY MANUFACTURER?YES. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 213. H6. INVESTIGATION CONCLUSIONS UPDATED TO 67.

    Additional Manufacturer Narrative · 0

    THIS MDR IS RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS. THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    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
    1979727 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QCD SENSEONICS INC. 102620-67A WP08435 00817491022356

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male