BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5471979 · Received March 1, 2016

    Report

    Report Number
    3004753838-2016-01341
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 3, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    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) DESCRIBE EVENT OR PROBLEM - ADDITIONAL, DEVICE AVAILABLE FOR EVALUATION - ADDITIONAL, ADDITIONAL INFORMATION/DEVICE EVALUATION, DEVICE EVALUATED BY MANUFACTURER - ADDITIONAL, EVENT PROBLEM AND EVALUATION CODES - ADDITIONAL.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT THAT ON (B)(6) 2016, THE G5 TRANSMITTER WOULD NOT PAIR WITH THE G5 APPLICATION. PATIENT CONFIRMED SMART DEVICE IS NOT IN AIRPLANE MODE AND WI-FI IS ENABLED. PATIENT STATED THEY RE-INSTALLED G5 APPLICATION AND RESTARTED SMART DEVICE, BUT IT IS STILL NOT CONNECTING. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127734 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-06 5206846 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR