BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9555358 · Received January 6, 2020

    Report

    Report Number
    3004753838-2020-001350
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 11, 2019
    Report Date
    January 6, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CONNECTION ISSUES OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS SIGNAL LOSS OVER AN HOUR. THE PROBABLE CAUSE WAS DETERMINED TO BE THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. THE REPORTED EVENT OF CONNECTION ISSUES IS REPORTABLE BASED ON THE FINDING OF A SIGNAL LOSS OVE 1 HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15773 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5259330 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR