BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6023450 · Received October 12, 2016

    Report

    Report Number
    3004753838-2016-86783
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 18, 2016
    Report Date
    September 18, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000231
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT THE DISPLAY DEVICE READ FAILED TRANSMITTER ERROR ON (B)(6) 2016. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT RECEIVER WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GF-001 /SERIAL NUMBER (B)(4)/LOT NUMBER 5210424) WAS RETURNED ON 09/26/2016. THE TRANSMITTER WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO OBSERVATIONS WERE FOUND RELATED TO THE CUSTOMER COMPLAINT. A VOLTAGE TEST WAS PERFORMED AND FAILED INDICATING NO VOLTAGE ON THE UNIT. NO DATA RELATED TO THE CUSTOMER COMPLAINT WAS OBSERVED DURING SHARE LOG REVIEW. THE REPORTED ISSUE OF FAILED TRANSMITTER ERROR WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672097 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719 5210424 00386270000231

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR