BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 4841032 · Received June 12, 2015

    Report

    Report Number
    3004753838-2015-31321
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND PASSED EXTERIOR VISUAL INSPECTION. GLOBAL RECEIVER FUNCTIONAL TESTING RESULTED IN NO FAILURES RELATED TO THE CUSTOMER COMPLAINT. NO ERRORS RELATED TO THE INCIDENT WERE FOUND DURING A REVIEW OF THE RECEIVER DATA LOG. THE DEVICE PASSED MANUAL SOUND DROP TESTING. THE REPORTED FAULT COULD NOT BE REPRODUCED. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT NO AUDIO OUTPUT FROM THE RECEIVER THAT OCCURRED ON (B)(6) 2015. AT THE TIME OF CONTACT, THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385994 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495 5197918

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR