BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6519417 · Received April 25, 2017

    Report

    Report Number
    3004753838-2017-26318
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    March 28, 2017
    Report Date
    March 28, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    10386270000061
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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."

    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 (B)(6) 2017 THAT ON (B)(6) 2017, THE RECEIVER CEASED TO FUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT OF THE RECEIVER CEASED TO FUNCTION COULD NOT BE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299205 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT20649 5195775 10386270000061

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR