BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4863985 · Received June 23, 2015

    Report

    Report Number
    3004753838-2015-31462
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 28, 2015
    Report Date
    May 28, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    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)

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT NO AUDIO OUTPUT FROM THE RECEIVER THAT OCCURRED ON (B)(6) 2015. AT THE TIME OF CONTACT, THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404747 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-BLU 5106250

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR