BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7431700 · Received April 14, 2018

    Report

    Report Number
    3004753838-2018-039827
    Event Type
    Malfunction
    Date Received
    April 14, 2018
    Date of Event
    March 16, 2018
    Report Date
    October 16, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 WITH THE SAME DEVICE. 180314-000668 180314-000734 180314-000749 180314-001113 180314-001163 180314-001198 180314-001207 180314-001221 180314-001228 180314-001242 180314-001255 180314-001266 180314-001276 180314-001292 180314-001307 180314-001317 180314-001335 180314-001348 180314-001365 180314-001389 180314-001398 180314-001413 180314-001426 180314-001448 180314-001459 180314-001483 180314-001492 180314-001504 180314-001512 180314-001518 180314-001526 180314-001539 180314-001557 180314-001563 180314-001570 180314-001577 180314-001588 180316-000232 180316-000108

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018 A LOSS OF CONNECTION HAD OCCURRED. NO PRODUCT WAS PROVIDED FOR EVALUATION HOWEVER DATA HAS BEEN RECEIVED FOR INVESTIGATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF DATA INVESTIGATION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274459 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR