BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6061153 · Received October 27, 2016

    Report

    Report Number
    3004753838-2016-67562
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 8, 2016
    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

    DEXCOM WAS MADE AWARE ON 10/08/2016 THAT ON (B)(6) 2016, THERE WERE INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2016. REPORTEDLY, THE PATIENT DID NOT CALIBRATE AFTER THE INACCURACY OR ENTER FINGER STICK VALUES PROMPTLY. 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: IF THE DIFFERENCE BETWEEN YOUR SENSOR GLUCOSE READING AND BLOOD GLUCOSE VALUE IS GREATER THAN 20% OF THE BLOOD GLUCOSE VALUE FOR SENSOR GLUCOSE READINGS > 80 MG/DL OR GREATER THAN 20 POINTS FOR SENSOR GLUCOSE READINGS < 80 MG/DL, WASH YOUR HANDS AND TAKE ANOTHER BLOOD GLUCOSE MEASUREMENT. IF THE DIFFERENCE BETWEEN THIS SECOND BLOOD GLUCOSE MEASUREMENT AND THE SENSOR IS STILL GREATER THAN 20% FOR SENSOR GLUCOSE READINGS > 80 MG/DL OR GREATER THAN 20 POINTS FOR SENSOR GLUCOSE READINGS < 80 MG/DL, RECALIBRATE YOUR SENSOR USING THE SECOND BLOOD GLUCOSE VALUE. THE SENSOR GLUCOSE READING WILL CORRECT OVER THE NEXT 15 MINUTES. FURTHERMORE, THE GUIDE STATES: TO CALIBRATE THE SYSTEM, ENTER THE EXACT BLOOD GLUCOSE VALUE THAT YOUR BLOOD GLUCOSE METER DISPLAYS WITHIN 5 MINUTES OF A CAREFULLY PERFORMED BLOOD GLUCOSE MEASUREMENT. ENTERING INCORRECT BLOOD GLUCOSE VALUES OR BLOOD GLUCOSE VALUES FROM MORE THAN 5 MINUTES BEFORE ENTRY MIGHT AFFECT SENSOR PERFORMANCE, AND YOU MIGHT MISS A LOW OR HIGH BLOOD GLUCOSE VALUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711926 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5214520 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR