BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4841060 · Received June 12, 2015

    Report

    Report Number
    3004753838-2015-31337
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S GIRLFRIEND CONTACTED DEXCOM TECHNICAL SUPPORT ON 05/18/2015 TO REPORT INTERMITTENT AUDIO OUTPUT FROM THE RECEIVER THAT OCCURRED ON 05/18/2015. AT THE TIME OF CONTACT, THE PATIENT'S GIRLFRIEND DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385360 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5091234

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR