BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6545762 · Received May 4, 2017

    Report

    Report Number
    3004753838-2017-37728
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    April 12, 2017
    Report Date
    April 12, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    30386270000270
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, ON 05/30/2017, IT WAS LEARNED THAT THE PATIENT'S FATHER REPORTED THAT THE RECEIVER WAS STUCK ON THE BOOT-UP SCREEN; THEREFORE THIS IS A NON-REPORTABLE EVENT. A RECEIVER (SERIAL NUMBER (B)(4)/LOT NUMBER 5222058) WAS RETURNED FOR EVALUATION. THE RECEIVER DID NOT BOOT UP AND WAS RE-INITIALIZING CONTINUOUSLY, CONFIRMING AN ISSUE OF INITIALIZING; HOWEVER, THE INVESTIGATION RESULTS ARE IRRELEVANT TO THE REPORTED EVENT THAT OCCURED. NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017, THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED ERR121. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326739 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719-BLU 5222058 30386270000270

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR