BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7681631 · Received July 12, 2018

    Report

    Report Number
    3004753838-2018-076072
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 15, 2018
    Report Date
    June 15, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)..

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON 06/15/2018, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON 06/15/2018. DATA WAS RECEIVED FOR EVALUATION, THE DATA LOG CONFIRMED THE REPORT OF AN INACCURACY. ADDITIONALLY, IT WAS DETERMINED VIA DATA THAT CALIBRATIONS WERE ENTERED DURING PERIODS OF RAPID RATE OF CHANGE. THE PROBABLE CAUSE WAS DETERMINED TO BE IMPROPER CALIBRATION DURING A RAPID RISE OR FALL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523052 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 NI 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR