BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8805450 · Received July 18, 2019

    Report

    Report Number
    3004753838-2019-54502
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    May 24, 2019
    Report Date
    July 18, 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).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597256 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM INC. 9438-06 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR