BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3870580 · Received June 12, 2014

    Report

    Report Number
    3004753838-2014-09542
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 8, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 THEY WERE CONTACTED BY A PATIENT WHO EXPERIENCED A HARDWARE FAILURE ON (B)(6) 2014. INTERNATIONAL DISTRIBUTOR DID NOT REPORT 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
    348015 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-2 5122250

    Patients

    Seq Age Sex Outcome Treatment
    1 Other