BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6380983 · Received March 6, 2017

    Report

    Report Number
    3004753838-2017-15424
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Date of Event
    February 10, 2017
    Report Date
    February 10, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    10386270000221
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF. PRODUCT CODE PQF IS NOT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2017 THAT ON (B)(6) 2017, PATIENT EXPERIENCED A FAILED TRANSMITTER ERROR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162489 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9438-06 5216398 10386270000221

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR