BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8621435 · Received May 17, 2019

    Report

    Report Number
    3004753838-2019-42830
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 17, 2019
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOSS OF CONNECTION OCCURRED. IT WAS DETERMINED THAT THE LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. DATA WAS RECEIVED FOR EVALUATION. HOWEVER, THE ALLEGED PRODUCT AND/OR ISSUE IS NOT PRESENT WITHIN THE INVESTIGATION WINDOW. CONFIRMATION OF THE ALLEGATION AND A ROOT CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415151 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR