BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5982180 · Received September 27, 2016

    Report

    Report Number
    3004753838-2016-73878
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 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).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT THE PATIENT EXPERIENCED CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2016. SENSOR WAS INSERTED ON (B)(6) 2016 INTO THE ARM. LABELING INDICATES: DO NOT INSERT THE SENSOR COMPONENT OF THE DEXCOM G5 MOBILE SYSTEM IN A SITE OTHER THAN THE BELLY/ABDOMEN (AGES 2 YEARS AND OLDER) OR THE UPPER BUTTOCKS (AGES 2 TO 17 YEARS). THE PLACEMENT AND INSERTION OF THE SENSOR COMPONENT OF THE DEXCOM G5 MOBILE SYSTEM IS NOT APPROVED FOR OTHER SITES. IF PLACED IN OTHER AREAS, THE DEXCOM G5 MOBILE SYSTEM MAY NOT FUNCTION PROPERLY. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE RECEIVER DATA LOG WAS REVIEWED ON 09/14/2016. THE COMPLAINT OF INACCURATE CGM VALUES WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633419 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5216107 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR