BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6238063 · Received January 10, 2017

    Report

    Report Number
    3004753838-2017-00017
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    October 4, 2016
    Report Date
    December 14, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Removal / Correction Number
    3004753838-02/29/16-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) THIS MDR IS ASSOCIATED WITH MDR REPORT NUMBER 3004753838-2017-100017.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 12/14/2016, 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

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. PERFORMED VOLTAGE TEST AND PASSED. . NORDIC BLUETOOTH PAIRING TEST: PASS. TESTED ON GLOBAL TRANSMITTER FINAL FUNCTIONAL TESTER: PASSED RELEVANT TESTING. PERFORMED SHARE LOG REVIEW AND A LOSS OF CONNECTION WAS FOUND. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS MDR IS ASSOCIATED WITH MDR REPORT NUMBER 3004753838-2017-100017

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19884 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719-1 5215920

    Patients

    Seq Age Sex Outcome Treatment
    1