BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7594478 · Received June 12, 2018

    Report

    Report Number
    3004753838-2018-63843
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    May 17, 2018
    Report Date
    May 18, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). "DEXCOM WAS MADE AWARE ON 05/18/2018 THAT ON (B)(6) 2018 THE RECEIVER CEASED TO FUNCTION. THE COMPLAINT CONFIRMATION OF THE RECEIVER CEASING TO FUNCTION COULD NOT BE DETERMINED."

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 05/18/2018 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.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 05/18/2018 THAT ON (B)(6) 2018 THE RECEIVER SHUT DOWN UNEXPECTEDLY...THE COMPLAINT CONFIRMATION OF THE UNEXPECTED RECEIVER SHUTDOWN 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 FAILED TO CHARGE AND REBOOT. THE RECEIVER CASE WAS OPENED, THE INTERNAL INSPECTION PASSED. THE RECEIVER LOG WAS DOWNLOADED WITH A KNOWN GOOD BATTERY, RTTLOSS WAS OBSERVED. THE BATTERY WRAP WAS CUT AND INSPECTED AND IT FAILED WITH A BAD BATTERY. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO THE RECEIVER NOT BOOTING UP. THE REPORTED EVENT OF UNEXPECTED RECEIVER SHUTDOWN WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433355 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719-1 5225061

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR