BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 18707948 · Received February 14, 2024

    Report

    Report Number
    3004753838-2024-038853
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    January 21, 2024
    Report Date
    February 14, 2024
    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
    SC, US
    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) 2024. ON 01-21-2024, THE WIFE DISCOVERED THE PATIENT OUT OF IT WITH MUSCLE SPASMS. THE WIFE CHECKED THE DEXCOM WAS READING 250 MGDL, BUT SHE FELT SOMETHING WAS OFF SO THEY CALLED EMERGENCY MEDICAL SERVICE (EMS). WHEN EMS ARRIVED, THEY GAVE THE PATIENT INTRAVENOUS SUGAR SOLUTION AND GOT A BG OF 27 MGDL WHILE THE DEXCOM WAS STILL AT 250 MGDL. EMS BROUGHT THE PATIENT TO THE EMERGENCY ROOM WHERE THE NURSES CONTINUED THE INTRAVENOUS SUGAR SOLUTION AND GAVE THE PATIENT A NASAL CANNULA FOR ADDITIONAL OXYGEN. OF NOTE, THE PATIENT WAS ALSO HYPERTENSIVE. THE PATIENT UNDERWENT TESTING INCLUDING X-RAYS AND COMPUTED TOMOGRAPHY (CT) SCANS. THERE WAS NO DOCUMENTATION OF FURTHER MEDICAL EVALUATION OR INTERVENTION FOR SYMPTOMATIC HYPOGLYCEMIA AND THE PATIENT WAS DISCHARGED (B)(6) 2024. THE PATIENT WAS REPORTEDLY FINE THE SAME DAY AS DISCHARGE. NO OTHER DETAILS WERE DOCUMENTED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE E ZONE OF THE PARKES ERROR GRID. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225211 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9535-45 7335459 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other| H