BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7904009 · Received September 24, 2018

    Report

    Report Number
    3004753838-2018-112609
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    August 26, 2018
    Report Date
    February 20, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000804
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIALLY THIS EVENT WAS REPORTED AS A REPORTABLE MALFUNCTION. UPON FURTHER REVIEW IT WAS DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE COMPLAINT. MFR 3004753838-2018-112609 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT SINCE THIS HAS NOW BEEN DEEMED NON-REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT THE REPORT WAS SUBMITTED IN ERROR. LOSS OF CONNECTION DID NOT OCCUR AND THEREFORE THE CRITERIA OF A REPORTABLE COMPLAINT IS NOT MET AS PER THE CODE OF FEDERAL REGULATIONS.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. IT WAS DETERMINED THAT LOSS OF CONNECTION WAS RELATED TO THE MOBILE APPLICATION. A DATA INVESTIGATION WILL NOT BE PERFORMED AS SIGNAL LOSS UP TO ONE HOUR IS WITHIN SPECIFICATION. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742728 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. N/A 00386270000804

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR