BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6049257 · Received October 21, 2016

    Report

    Report Number
    3004753838-2016-72819
    Event Type
    Malfunction
    Date Received
    October 21, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 30, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000279
    PMA / PMN Number
    P120005
    Removal / Correction Number
    3004753838-02/29/16-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4) MODEL NUMBER - CORRECTION, CATALOG NUMBER - CORRECTION, SERIAL NUMBER - CORRECTION, LOT NUMBER - CORRECTION, UDI NUMBER - CORRECTION, IF FOLLOW-UP, WHAT TYPE?: CORRECTION, DEVICE MANUFACTURE DATE - CORRECTION TO REMOVE, EVENT PROBLEM AND EVALUATION CODES - CORRECTION TO REMOVE (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 09/30/2016, TO CLAIM NO AUDIO OUTPUT ON (B)(6) 2016. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A RECEIVER (PART NUMBER STR-GF-BLU/ MODEL NUMBER MT22719-BLU/ SERIAL NUMBER (B)(4)/ LOT NUMBER 5211984) WAS RETURNED FOR EVALUATION ; HOWEVER IT CAN NOT BE DETERMINED IF THIS IS THE COMPLAINT DEVICE. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. A "TRY IT" MANUAL TEST WAS PERFORMED AND SPEAKER SOUNDED. THE REPORTED EVENT OF NO AUDIO OUTPUT WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698288 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719-BLU 5211983 00386270000279

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR