BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 10025389 · Received May 5, 2020

    Report

    Report Number
    3004753838-2020-042084
    Event Type
    Injury
    Date Received
    May 5, 2020
    Date of Event
    April 11, 2020
    Report Date
    May 5, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    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 UPPER BUTTOCKS, WHICH IS OFF LABEL USAGE OF THE DEVICE, ON (B)(6) 2020. THE PATIENT¿S HUSBAND STATED ON (B)(6) 2020, THE PATIENT¿S BG VALUE WAS 150 MG/DL BUT THE CGM WAS READING 200 MG/DL. HE ALSO STATED THAT ON (B)(6) 2020, 911 WAS CALLED DUE TO AN URGENT LOW, WHICH IS DISCREPANT FROM THE VALUES PREVIOUSLY STATED. HE REPORTED THAT DURING THE URGENT LOW EVENT HER BG WAS 20 MG/DL LOWER THAT THE URGENT LOW, OR WHATEVER WAS DISPLAYED ON HER CGM, BUT HE DID NOT PROVIDE ANY SPECIFIC BG OR CGM VALUES OR ANY SYMPTOM INFORMATION. NO EMERGENCY MEDICAL SERVICES (EMS) TREATMENT INFORMATION WAS PROVIDED. AT THE TIME OF THE REPORT THE PATIENT WAS HEALTHY WITH NO ISSUES. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. THIS IS BEING REPORTED DUE TO ADVERSE EVENT AND/OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487877 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 7268836 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other