BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 14074687 · Received April 11, 2022

    Report

    Report Number
    3004753838-2022-042910
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    February 19, 2022
    Report Date
    April 11, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORTER EMAIL ADDRESS - (B)(6). THIS MDR WAS PREVIOUSLY SUBMITTED ON 03/21/22 AT 01:09 PM PST WITH MFR# 3004753838-2022-042910. THE ACK2 WAS RECEIVED ON 03-21-2022 AT 16:21:38 WITH COREID: CI1647894020919.20432170@FDSLV86005_TE1 DAY 25. PER CDRH/CESUB ¿WE ARE UNABLE TO LOCATE THE BELOW SUBMISSIONS. THEY WERE NOT RECEIVED. PLEASE CHECK YOUR SUBMISSIONS FOR ANY ISSUES, REPACKAGE THEM PROPERLY AND RESUBMIT THEM." AS PER ESG/CDRH EMAIL ON 3/18/2022, THIS SUBMISSION IS CONSIDERED A TIMELY SUBMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SIGNAL LOSS OVER ONE HOUR OCCURRED. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND SIGNAL LOSS WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581059 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-24 5293742

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male