BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3875050 · Received June 16, 2014

    Report

    Report Number
    3004753838-2014-17684
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    November 1, 2013
    Report Date
    November 1, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE AND REVIEW OF THE DATA LOG CONFIRMED THE REPORTED HARDWARE ERROR CODE ON THE RECEIVER.

    Description of Event or Problem · 1

    CONSUMER CONTACTED DEXCOM TO REPORT A HARDWARE ERROR ON THE RECEIVER. THE CONSUMER DID NOT REPORT ANY MEDICAL INTERVENTION OR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353097 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR