BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6137036 · Received November 30, 2016

    Report

    Report Number
    3004753838-2016-57432
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 8, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 ON (B)(6) 2016, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE THIGH ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED. REVIEW OF THE DATA LOG CONFIRMED THE REPORTED INACCURACY. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786913 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR