BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8136131 · Received December 5, 2018

    Report

    Report Number
    3004753838-2018-151732
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 8, 2018
    Report Date
    November 9, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) - CORRECTION "P170031"

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT THE DISPLAY DEVICE SHOWED A TRANSMITTER FAILED ERROR ON (B)(6) 2018 . NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A TRANSMITTER FAILED ERROR WAS CONFIRMED VIA DATA. A ROOT CAUS WASE BE A LOW BATTERY THAT LED TO A TRANSMITTER FAILURE.

    Description of Event or Problem · 1

    THE PRODUCT WAS EVALUATED. THE DEVICE WAS VISUALLY INSPECTED AND IT PASSED. A VOLTAGE TEST WAS PERFORMED AND IT FAILED DUE TO NO VOLTAGE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A FAILED TRANSMITTER ERROR WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE LOW TRANSMITTER BATTERY THAT LEAD TO A FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975247 DEXCOM G6 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5240512

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR