BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7364236 · Received March 22, 2018

    Report

    Report Number
    3004753838-2018-29473
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 21, 2018
    Report Date
    February 23, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). "DEXCOM WAS MADE AWARE ON 02/23/2018 THAT ON (B)(6) 2018 THE RECEIVER CEASED TO FUNCTION...THE COMPLAINT CONFIRMATION OF THE RECEIVER CEASING TO FUNCTION COULD NOT BE DETERMINED."

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 02/23/2018 THAT ON (B)(6) 2018 THERE WAS UNEXPECTED RECEIVER SHUT-DOWN...THE COMPLAINT CONFIRMATION OF UNEXPECTED RECEIVER SHUT-DOWN COULD NOT BE DETERMINED. THE COMPLAINT RECEIVER DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EXTERNALLY VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. THE RECEIVER WAS ABLE TO BE CHARGED AND REBOOTED. FUNCTIONAL TESTING WAS PERFORMED AND IT PASSED. THE RECEIVER LOG WAS DOWNLOADED, THE DATA CONTAINS NO ISSUES RELATED TO COMPLAINT. THE RECEIVER CASE WAS OPENED AND THE INTERNAL INSPECTION PASSED. THE REPORTED EVENT OF UNEXPECTED RECEIVER SHUTDOWN WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 02/23/2018 THAT ON (B)(6) 2018 THE RECEIVER CEASED TO FUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF THE RECEIVER CEASING TO FUNCTION COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206806 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719-2 5230569

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR