BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4745691 · Received May 4, 2015

    Report

    Report Number
    3004753838-2015-03460
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 6, 2015
    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

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE RECEIVER ((B)(4)) THAT WAS USED WITH THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION ON 04/30/2015. A FOLLOW-UP REPORT WIL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, RECEIVER DEVICE (PART NUMBER STR-GL-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5191739), BEING USED WITH THE COMPLAINT TRANSMITTER DEVICE, WAS RETURNED ON (B)(4) 2015 FOR EVALUATION. THE RETURNED COMPLAINT RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A REVIEW OF THE DOWNLOADED RECEIVER LOG FOUND A HARDWARE ERROR CODE. THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE COMPONENT FAILURE. 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.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED AN INTERMITTENT OUT OF RANGE SIGNAL. AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290763 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01 5133250

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR