BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9644930 · Received January 29, 2020

    Report

    Report Number
    3004753838-2020-009517
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 9, 2020
    Report Date
    January 29, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000385
    PMA / PMN Number
    DEN170088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MY APP LOST CONNECTION WITH MY BLUETOOTH OVERNIGHT ALTHOUGH MY PHONE WAS RIGHT BESIDE ME. IT WILL NOT REJOIN. PREFERRED CONTACT TIME: 9:00 AM - EST1/15/2020  DMENDOZA: EMAIL SENT TO [email protected]/15/2020  DMENDOZA: ATTEMPTED REACH OUT ON (617) 894-2906 2:45 PM EST. LEFT VM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106780 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9445-02 5263677 00386270000385

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR