BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7671859 · Received July 9, 2018

    Report

    Report Number
    3004753838-2018-074410
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Date of Event
    June 4, 2018
    Report Date
    July 11, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 180708-001437 180708-001449 180708-001457 180708-001465 180708-001469 180708-001476 180708-001485 180708-001490 180708-001497 180708-001507 180708-001519 180708-001524 180708-001535 180708-001548 180708-001554 180708-001562 180708-001589 180708-001593 180708-001603 180708-001626 180708-001631 180708-001652 180708-001655 180708-001660 180708-001664 180708-001671 180708-001676 180708-001683 180708-001693 180708-001712 180708-001715 180708-001661 180708-001668 180708-001675 180708-001685 180708-001725 180708-001730 180708-001737 180708-001745 180708-001749 180708-001754 180708-001757 180708-001763 180708-001769 180708-001779 180708-001784 180708-001788 180708-001807 180708-001810 180708-001814 180708-001819 180708-001826

    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. DATA WAS PROVIDED FOR EVALUATION. LOSS OF CONNECTION WAS CONFIRMED. A PROBABLE CAUSE WAS DETERMINED TO BE THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511311 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR