BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM

    MDR report key: 12960852 · Received December 8, 2021

    Report

    Report Number
    3004753838-2021-309050
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 8, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QDK
    PMA / PMN Number
    K203089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE,ON (B)(6) 2021. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION OR THE CALIBRATIONS DURING THE REPORTED SENSOR SESSION WERE IN ACCURATE RANGE PER DEVICE SPECIFICATIONS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861494 DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM CONTINUOUS GLUCOSE MONITOR QDK DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female