BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5142415 · Received October 10, 2015

    Report

    Report Number
    3004753838-2015-90393
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 15, 2015
    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

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 REPORT ABOUT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AND THE BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. THE PATIENTS SENSOR WAS INSERTED ON (B)(6) 2015 ON THE ARM. THE PATIENT'S MOTHER DID NOT REPORT INJURY OR MEDICAL INTERVENTION. IT WAS REPORTED THAT THE SENSOR WAS WORN AFTER SENSOR'S EXPIRATION DATE. THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USERS GUIDE STATES: YOUR SENSOR GIVES YOU SENSOR GLUCOSE READINGS FOR UP TO SEVEN DAYS. THE PERFORMANCE OF A SENSOR HAS NOT BEEN TESTED BEYOND SEVEN DAYS. IT WAS REPORTED THAT THE SENSOR WAS INSERTED INTO THE ARM. THE DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: DO NOT INSERT THE SENSOR IN SITES OTHER THAN THE BELLY (ABDOMEN) OR UPPER BUTTOCKS. USE IN OTHER SITES MIGHT CAUSE SENSOR GLUCOSE READINGS TO BE INACCURATE AND COULD RESULT IN YOU MISSING SEVERE HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) EVENTS. IT WAS REPORTED THAT A PEDIATRIC PATIENT WAS USING AN ADULT RECEIVER. IT SHOULD BE NOTED THAT THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: THE DEXCOM G4 SYSTEM IS NOT APPROVED FOR USE IN CHILDREN OR ADOLESCENTS, PREGNANT WOMEN OR PERSONS ON DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674028 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5191705 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR