BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM

    MDR report key: 5669920 · Received May 20, 2016

    Report

    Report Number
    3004753838-2016-37974
    Event Type
    Malfunction
    Date Received
    May 20, 2016
    Date of Event
    April 19, 2016
    Report Date
    April 24, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2016. SENSOR WAS INSERTED ON (B)(6) 2016. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE RECEIVER DATA LOG WAS REVIEWED ON 05/12/2016. THE COMPLAINT OF INACCURATE CGM VALUES WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE RECEIVER (PART NUMBER STR-GF-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5210040), BEING USED WITH THE COMPLAINT SENSOR, WAS RETURNED ON 06/02/2016. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT CONFIRM THE REPORTED EVENT OF INACCURACIES. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324520 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM MDS MDS DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR