BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6195582 · Received December 21, 2016

    Report

    Report Number
    3004753838-2016-94183
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 12/02/2016, 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 AT THE ABDOMEN ON (B)(6) 2016. REPORTEDLY, CALIBRATION WAS NOT PERFORMED AFTER THE INACCURACY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846463 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR