BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6417913 · Received March 20, 2017

    Report

    Report Number
    3004753838-2017-13858
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 14, 2017
    Report Date
    February 23, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    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. PERFORMED A PAIRING TEST WITH A NORDIC BLUETOOTH DEVICE AND PASSED. PERFORMED SHARE LOG REVIEW AND NO DATA FOUND. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED BECAUSE THERE IS NO DATA AVAILABLE AND THE TRANSMITTER CANNOT BE TESTED.. THE CUSTOMER COMPLAINT WAS UNDETERMINED BECAUSE LAB TESTING PASSES BUT RELEVANT DATA IS UNAVAILABLE.. A ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, A RECEIVER (B)(4) AND LOT NUMBER 5222359 WAS RETURNED. AN EXTERNAL VISUAL INSPECTION PASSED.THE RECEIVER WLL CHARGE AND BOOT. RECEIVER PASSED ALL FUNCATIONAL TESTING.PERFORMED SHARE LOG REVIEW AND DATA LOG CONFIRMED CUSTOMER COMPLAINT.. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE PATIENT EXPERIENCED GAPS IN DATA. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200746 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 6000698

    Patients

    Seq Age Sex Outcome Treatment
    1