BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8028426 · Received November 1, 2018

    Report

    Report Number
    3004753838-2018-133726
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 2, 2018
    Report Date
    March 5, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 10/03/2018 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2018. THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 10/03/2018 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6)2018. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED, AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED, AND THE TEST FAILED. A REVIEW OF THE DOWNLOADED DATA LOG CONFIRMED THE REPORTED EVENT OF A FAILED TRANSMITTER ERROR. THE PROBABLE CAUSE WAS DETERMINED TO BE A LOW TRANSMITTER BATTERY. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868828 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5240503 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR