BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6178424 · Received December 15, 2016

    Report

    Report Number
    3004753838-2016-88872
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 26, 2016
    Report Date
    November 27, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 11/27/2016 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 INTO THE ABDOMEN ON (B)(6) 2016. REPORTEDLY, THE PATIENT DID NOT WASH AND DRY THEIR HANDS PRIOR TO TAKING THEIR FINGERSTICK MEASUREMENT FOR CALIBRATION. 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: BEFORE YOU TAKE A BLOOD GLUCOSE VALUE FOR CALIBRATION, WASH YOUR HANDS, MAKE SURE YOUR GLUCOSE TEST STRIPS HAVE BEEN STORED PROPERLY AND ARE NOT EXPIRED AND MAKE SURE THAT YOUR METER IS PROPERLY CODED (IF REQUIRED). CAREFULLY APPLY THE BLOOD SAMPLE TO THE TEST STRIP FOLLOWING THE INSTRUCTIONS THAT CAME WITH YOUR METER OR TEST STRIPS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827756 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5211877 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR