BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4863769 · Received June 23, 2015

    Report

    Report Number
    3004753838-2015-22799
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 28, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A REVIEW OF THE DOWNLOADED RECEIVER LOG CONFIRMED THE REPORTED EVENT OF A FIRMWARE ERROR. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM REV. 11, UNDER SECTION 13.8.2 RECEIVER ERROR CODE NOTES THE FOLLOWING: THIS SCREEN SHOWS AN ERROR CODE THAT MEANS THE RECEIVER MAY NOT BE WORKING PROPERLY. WRITE DOWN THE ERROR CODE AND CONTACT DEXCOM TECHNICAL SUPPORT. CONTINUE TO CHECK YOUR BLOOD GLUCOSE VALUE USING YOUR BLOOD GLUCOSE METER. NO ALERT SOUND OR VIBRATION WILL WARN YOU THAT YOU ARE NO LONGER GETTING SENSOR GLUCOSE READINGS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOREIGN PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT THE RECEIVER DISPLAYED A FIRMWARE ERROR ON (B)(6) 2015. THE FOREIGN PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407202 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-2 5200547

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR