BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5686852 · Received May 27, 2016

    Report

    Report Number
    3004753838-2016-08150
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    April 29, 2016
    Report Date
    April 29, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000231
    PMA / PMN Number
    P120005
    Removal / Correction Number
    3004753838-02/29/16-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO CLAIM INTERMITTENT AUDIO OUTPUT ON (B)(6) 2016. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. A "TRY IT" MANUAL TEST WAS PERFORMED AND SPEAKER SOUNDED. THE REPORTED EVENT OF AN INTERMITTENT AUDIO OUTPUT WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY THE TRANSMITTER (PART NUMBER STT-GF-001 /SERIAL NUMBER (B)(4)/LOT NUMBER 5210264), BEING USED WITH THE COMPLAINT RECEIVER, WAS RETURNED ON 05/27/2016. THE RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341529 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22719 5211964 00386270000231

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR