BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8623950 · Received May 20, 2019

    Report

    Report Number
    3004753838-2019-042336
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 22, 2019
    Report Date
    May 20, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    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 A LOW TRANSMITTER BATTERY ALERT OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE LOW TRANSMITTER BATTERY VOLTAGE. IN ADDITION, A FAILED TRANSMITTER ERROR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE REPORTED ISSUE OF A LOW TRANSMITTER BATTERY ALERT IS REPORTABLE BASED ON THE FINDING OF A FAILED TRANSMITTER ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417128 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 5249162

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR