BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4171239 · Received October 14, 2014

    Report

    Report Number
    3004753838-2014-29421
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND FOUND NO OBSERVATIONS RELATED TO THE COMPLAINT. REPORTED FAULT COULD NOT BE REPRODUCED FOR THE RECEIVER. A REVIEW OF THE RECEIVER DATA LOG CONFIRMED A HARDWARE ERROR CODE. THIS COMPLAINT WAS DEEMED REPORTABLE UPON COMPLETION OF DEVICE EVALUATION ON 09/18/2014. CUSTOMER COMPLAINT WAS CONFIRMED BY THE LOG. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT A HARDWARE ERROR MESSAGE PATIENT EXPERIENCED ON (B)(6) 2014. PATIENT'S MOTHER 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
    651671 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-BLU

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR