BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3864444 · Received June 10, 2014

    Report

    Report Number
    3004753838-2014-04732
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DEXCOM EMPLOYEE CONTACTED DEXCOM TECHNICAL SUPPORT ON BEHALF OF PATIENT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED NO AUDIBLE ALERTS. THREE SUBSEQUENT ATTEMPTS TO CONTACT THE PATIENT WERE MADE WITH NO SUCCESS. THERE WAS NO REPORT OF ANY INJURY OR MEDICAL INTERVENTION AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340795 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other