BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5469304 · Received February 29, 2016

    Report

    Report Number
    3004753838-2016-10806
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    January 7, 2016
    Report Date
    February 3, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5201949), BEING USED WITH THE COMPLAINT SENSOR, WAS RETURNED ON 03/08/2016. THE RETURNED TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THE REPORTED EVENT OF INACCURACIES WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT'S MOTHER 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. THE SENSOR WAS INSERTED ON (B)(6) 2016. IT WAS REPORTED THE SENOR WAS INSERTED IN THE ARM AND THAT AN ALTERNATIVE TESTING SITE (TOES) WAS USED TO TAKE BG READINGS. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION AND DATA WAS NOT PROVIDED; THEREFORE, THE REPORTED COMPLAINT OF INACCURACIES CANNOT BE CONFIRMED. IT WAS ALSO REPORTED THAT THE SENSOR WAS INSERTED IN THE ARM. IT SHOULD BE NOTED THAT 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. OTHER SITES HAVE NOT BEEN STUDIED AND ARE NOT APPROVED. 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. IN ADDITION, IT WAS REPORTED THAT AN ALTERNATIVE TESTING SITE WAS USED (ARM) TO CALIBRATE THE DEXCOM CGM SYSTEM. IT SHOULD ALSO BE NOTED THAT THE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: DO NOT USE ALTERNATIVE BLOOD GLUCOSE SITE TESTING (BLOOD FROM YOUR PALM OR FOREARM, ETC.) FOR CALIBRATION. ALTERNATIVE SITE BLOOD GLUCOSE VALUES MAY BE DIFFERENT THAN THOSE TAKEN FROM A FINGER STICK BLOOD GLUCOSE VALUE AND MAY NOT REPRESENT THE TIMELIEST BLOOD GLUCOSE VALUE. USE A BLOOD GLUCOSE VALUE TAKEN ONLY FROM A FINGER STICK FOR CALIBRATION. ALTERNATIVE SITE BLOOD GLUCOSE VALUES MIGHT AFFECT SENSOR PERFORMANCE, AND YOU MIGHT MISS A LOW OR HIGH BLOOD GLUCOSE VALUE. HOWEVER, A ROOT CAUSE FOR THE REPORTED INACCURACIES CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125761 DEXCOM G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500.27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR