BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6202365 · Received December 23, 2016

    Report

    Report Number
    3004753838-2016-94878
    Event Type
    Malfunction
    Date Received
    December 23, 2016
    Date of Event
    November 30, 2016
    Report Date
    November 30, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000224
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 ON (B)(6) 2016, PATIENT EXPERIENCED A LOSS OF CONNECTION BETWEEN THE TRANSMITTER AND SMART DEVICE. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A ROOT CAUSE COULD NOT BE DETERMINED. THE TRANSMITTER WAS RETURNED FOR EVALUATION. EXTERNAL VISUAL INSPECTION WAS PERFORMED AND THERE WERE NO OBSERVATIONS FOUND RELATED TO THE CUSTOMER COMPLAINT. A PAIRING TEST WITH THE (B)(6) DEVICE WAS PERFORMED AND PASSED AS IT WAS POSSIBLE TO DOWNLOAD THE TRANSMITTER LOG DURING THE TEST. THE GLOBAL TRANSMITTER FINAL FUNCTIONAL TEST WAS PERFORMED AND PASSED WITH NO DEFICIENCY. SHARE DATA LOG WAS REVIEWED AND LOSS OF CONNECTION WAS OBSERVED ON THE ISSUE DATE. THE REPORTED CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED POST INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852007 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 5210226 00386270000224

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR