BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7899805 · Received September 21, 2018

    Report

    Report Number
    3004753838-2018-110051
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 22, 2018
    Report Date
    August 22, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    SR-(B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE COMPLAINT AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, THIS RECORD HAS BEEN DETERMINED TO NOT BE REPORTABLE. PLEASE DISREGARD INITIAL REPORTING UNDER MFR# 3004753838-2018-110051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738260 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR