BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 SENSOR

    MDR report key: 19058969 · Received April 5, 2024

    Report

    Report Number
    MW5153602
    Event Type
    Malfunction
    Date Received
    April 5, 2024
    Report Date
    April 5, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED TO INFORM US THAT HE HAS BEEN HAVING SENSOR ISSUES. SENSOR STOPS WORKING ON DAY SEVEN OR EIGHT AND NEVER LAST THE FULL TEN DAYS. READINGS ARE INACCURATE EITHER ALWAYS HIGHER OR LOWER THAN METER VALUES. HE CONTACTED DEXCOM REGARDING THIS PROBLEM AND THEY OFFER HIM REPLACEMENTS. HE HAS BEEN THROUGH SEVEN SENSORS AND ALL HAVE THE SAME ISSUES. HE TRIED TO CONTACT DEXCOM AGAIN FRIDAY (B)(6) 2024 TO SPEAK WITH A "SUPERVISOR, CEO (CHIEF EXECUTIVE OFFICER) OR COO (CHIEF OPERATING OFFICER)" AND WAS UNSUCCESSFUL. REFERENCE REPORTS: MW5153599, MW5153600, MW5153601, MW5153603, MW5153604, MW5153605.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540861 DEXCOM G6 SENSOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male