BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8623610 · Received May 20, 2019

    Report

    Report Number
    3004753838-2019-043050
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 20, 2019
    Report Date
    March 2, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000323
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECEIVER REBOOTED WHEN THE SENSOR WAS STOPPED. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    THE RECEIVER WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. CHARGE AND BOOT TESTING WAS PERFORMED AND PASSED. A (B)(4) BLUETOOTH DEVICE PAIRING TEST WAS PERFORMED AND PASSED. A TRANSMITTER FUNCTIONAL TEST WAS PERFORMED AND PASSED ALL RELEVANT TESTS. A REVIEW OF THE RECEIVER LOGS WAS PERFORMED AND A REBOOT AFTER STOPPING SENSOR WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417892 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22949 5243144 00386270000323

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR