BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6298519 · Received February 2, 2017

    Report

    Report Number
    3004753838-2017-10552
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Date of Event
    January 12, 2017
    Report Date
    January 12, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    30386270000270
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. PRODUCT CODE PQF IS NOT CURRENTLY AVAILABLE.

    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 NOT PERFORMED BECAUSE THE RECEIVER DOES NOT BOOT UP. THE RECEIVER DOES NOT BOOT UP AND IS RE-INITIALIZING CONTINUOUSLY. THE CUSTOMER COMPLAINT WAS CONFIRMED DUE TO RECEIVER DOES NOT BOOT UP AND IS RE-INITIALIZING CONTINUOUSLY. THE REPORTED EVENT OF INITIALIZING SCREEN WITHOUT MANUAL RESTART WAS CONFIRMED. 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 RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS RECEIVED BUT FURTHER INVESTIGATION CANNOT BE PERFORMED TO CONFIRM THE PROBLEM AND DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 1

    PRODUCT TESTING WAS COMPLETED ON 10/23/2018, WE HAVE UPDATED OUR TESTING METHODS FOR PRODUCT REVIEW SINCE REPORTING OF THE PRIOR INVESTIGATION. THE RECEIVER WAS CHARGED AND WAS PERPETUALLY REBOOTING. THE RECEIVER CASE WAS OPENED AND THE INTERNAL INSPECTION PASSED. THE UI PCBA WAS DETACHED TO PERFORM A DOWNLOAD. THE RECEIVER LOG WAS REVIEWED, THERE WAS NO EVIDENCE OF INITIALIZATION SCREEN WITHOUT MANUAL RESTART IN THE INVESTIGATION WINDOW. THE REPORTED EVENT OF INITIALIZING SCREEN WITHOUT MANUAL RESTART WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78365 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22719-BLU 5220709 30386270000270

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR