BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5151793 · Received October 15, 2015

    Report

    Report Number
    3004753838-2015-76676
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 16, 2015
    Report Date
    September 17, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 TO REPORT ABOUT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AND THE BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. THE PATIENT'S SENSOR WAS INSERTED ON (B)(6) 2015 ON THE THIGH. THE PATIENT'S MOTHER DID NOT REPORT INJURY OR MEDICAL INTERVENTION. IT WAS REPORTED THAT THE SENSOR WAS INSERTED INTO THE THIGH. 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 CALIBRATION WAS NOT PERFORMED CORRECTLY. THE DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: A. DO NOT CALIBRATE IF THE OUT OF RANGE SYMBOL SHOWS IN THE STATUS AREA. B. DO NOT CALIBRATE IF THE GLUCOSE READING ERROR SYMBOL SHOWS IN THE STATUS AREA. C. DO NOT CALIBRATE IF YOUR BLOOD GLUCOSE VALUE IS BELOW 40 OR ABOVE 400 MG/DL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684569 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR