BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6042509 · Received October 19, 2016

    Report

    Report Number
    3004753838-2016-67366
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 1, 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).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 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 AT THE ABDOMEN ON (B)(6) 2016. REPORTEDLY, THE PATIENT ENTERED FINGER STICK VALUES DURING RAPID RATES OF CHANGE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED. REVIEW OF THE DATA LOG DID NOT CONFIRM THE REPORTED INACCURACY. A ROOT CAUSE COULD NOT BE DETERMINED VIA DATA. LABELING INDICATES: DON'T CALIBRATE WHEN YOUR BG IS CHANGING AT A SIGNIFICANT RATE: MORE THAN 2 MG/DL PER MINUTE. LOOK FOR RATE OF CHANGE ARROWS ON YOUR DISPLAY DEVICE SCREEN AND DON'T CALIBRATE WHEN YOU SEE: A SINGLE ARROW, POINTING UP, RISING 2-3 MG/DL EACH MINUTE. TWO ARROWS POINTING UP, RISING MORE THAN 3 MG/DL EACH MINUTE. SINGLE ARROW POINTING DOWN, FALLING 2-3 MG/DL EACH MINUTE. TWO ARROWS POINTING DOWN, FALLING MORE THAN 3 MG/DL EACH MINUTE. CALIBRATING DURING A SIGNIFICANT RISE/FALL OF YOUR BG MAY AFFECT ACCURACY OF SENSOR GLUCOSE READINGS, RESULTING IN YOU MISSING A SEVERE LOW OR HIGH GLUCOSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693665 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR