BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 16080754 · Received December 30, 2022

    Report

    Report Number
    3004753838-2022-244702
    Event Type
    Injury
    Date Received
    December 30, 2022
    Date of Event
    November 20, 2022
    Report Date
    December 30, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.

    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 ABDOMEN. ON (B)(6) 2022, THE PATIENT STATED THE CGM WAS DISPLAYING APPROXIMATELY 4.0 MMOL/L SO THEY ATE 3 PIECES OF TOAST. THE PATIENT THEN LAID DOWN THAT EVENING/NIGHT. WHEN THE PATIENT'S SON RETURNED HOME THAT SAME NIGHT, HE FOUND THE PATIENT. IT WAS NOT REPORTED WHAT STATE THE PATIENT WAS IN DURING THIS TIME. THE SON CALLED EMERGENCY MEDICAL TECHNICIAN'S (EMT). IT WAS REPORTED THAT WHEN THE PARAMEDICS WERE CALLED, THE CGM WAS DIPLAYING 2.3 MMOL/L AND THE BG WAS 4.7 MMOL/L. WHEN EMTS ARRIVED, THEY GAVE THE PATIENT A CAN OF SODA TO DRINK AND GLUCOSE TABLETS. THE EMTS LEFT WHEN THE PATIENT'S BG READING WAS 4.0 MMOL/L. DURING THAT TIME, THE CGM WAS DISPLAYING 5.7 MMOL/L. AT THE TIME OF THE REPORT, THE PATIENT WAS IN STABLE CONDITION. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354765 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other