BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8701120 · Received June 14, 2019

    Report

    Report Number
    3004753838-2019-48577
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 14, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRANSMITTER FAILED ERROR OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A LOW BATTERY THAT LED TO A TRANSMITTER FAILURE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    THE PRODUCT WAS EVALUATED. THE DEVICE WAS VISUALLY INSPECTED AND IT PASSED. A VOLTAGE TEST WAS PERFORMED AND IT FAILED DUE TO NO VOLTAGE. A REVIEW OF THE SHARE LOGS WAS PERFORMED AND A FAILED TRANSMITTER ERROR WAS FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE LOW TRANSMITTER BATTERY VOLTAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495149 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 7249112

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR