BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10215004 · Received June 30, 2020

    Report

    Report Number
    3004753838-2020-64934
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    November 24, 2018
    Report Date
    June 30, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IS THE THIRD TIME MY TRANSMITTER IS EXPIRING 4 WEEKS SHY OF THREE MONTHS WAS REPORTED OCCURRED. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS A TRANSMITTER FAILED ERROR WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINE TO BE A TRANSMITTER FAILED ERROR. THE REPORTED EVENT OF THIS IS THE THIRD TIME MY TRANSMITTER IS EXPIRING 4 WEEKS SHY OF THREE MONTHS IS REPORTABLE BASED ON THE FINDING OF A TRANSMITTER FAILED ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676600 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9438-06 NI 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR