BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4860335 · Received June 22, 2015

    Report

    Report Number
    3004753838-2015-05114
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    April 28, 2015
    Report Date
    May 27, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOREIGN DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6)2015 ON PATIENT'S BEHALF TO REPORT PERMANENT OUT OF RANGE ON (B)(6) 2015. AT THE TIME OF CONTACT THE FOREIGN DISTRIBUTOR DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. VOLTAGE TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT OF AN UNRECOVERABLE LOSS OF ANTENNA PASSED THRESHOLD COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402135 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-05 5197717

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR