BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4772109 · Received May 14, 2015

    Report

    Report Number
    3004753838-2015-40757
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    March 4, 2015
    Report Date
    April 17, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    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). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO DEFECTS. FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURE WAS DETECTED. THE REPORTED FAULT COULD NOT BE REPRODUCED WITH THE TRANSMITTER. CUSTOMER COMPLAINT COULD NOT BE VERIFIED.

    Description of Event or Problem · 1

    STUDY COORDINATOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT POSSIBLE GAPS IN DATA ON (B)(6) 2015. THE STUDY COORDINATOR DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317391 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5191568

    Patients

    Seq Age Sex Outcome Treatment
    1