BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6483413 · Received April 11, 2017

    Report

    Report Number
    3004753838-2017-17470
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    February 21, 2017
    Report Date
    March 16, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION TO REMOVE STATEMENT "THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF. PRODUCT CODE PQF IS NOT CURRENTLY AVAILABLE IN FIELD D.2B."

    Additional Manufacturer Narrative · 1

    (B)(4). THE G5 SYSTEM IS ASSOCIATED WITH PRODUCT CODE PQF.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 03/16/2017 THAT ON (B)(6) 2017, THE RECEIVER DISPLAYED A DOUBLE ARROW UP INDICATING A RAPID CHANGE WHEN THE PATIENT WAS LEVEL PER FINGER STICK. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262427 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-35 5220648

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR