BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6130430 · Received November 28, 2016

    Report

    Report Number
    3004753838-2016-70848
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 7, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 LEG ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED INACCURACY COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. 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
    779987 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR