BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7922607 · Received October 1, 2018

    Report

    Report Number
    3004753838-2018-114188
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    August 31, 2018
    Report Date
    October 18, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 09/03/2018 THAT ON (B)(6) 2018 THE PATIENT EXPERIENCED RECEIVING AN EARLY SENSOR EXPIRATION NOTICE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE COMPLAINT DEVICE HAS BEEN RECEIVED FOR DEVICE INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 09/03/2018 THAT ON (B)(6) 2018 THE PATIENT EXPERIENCED RECEIVING AN EARLY SENSOR EXPIRATION NOTICE. THE COMPLAINT TRANSMITTER WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE DEVICE PASSED A VOLTAGE TEST. THE DEVICE WAS PAIRED WITH A (B)(4) BLUETOOTH DEVICE AND PASSED. TRANSMITTER FUNCTIONAL TESTER: PASSED ALL RELEVANT TESTING. THE SHARE LOG WAS REVIEWED AND WAS NOT ABLE TO CONFIRM THE EARLY SENSOR EXPIRATION. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA PRODUCT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762480 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5239328 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR