BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 19346871 · Received May 17, 2024

    Report

    Report Number
    3004753838-2024-118395
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 19, 2024
    Report Date
    May 17, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA. HEALTH EFFECT - CLINICAL CODE - E014302 DECREASED LEVEL OF CONSCIOUSNESS.

    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, WHICH IS OFF-LABEL USAGE OF THE DEVICE, ON (B)(6) 2024. THE PATIENT EXPERIENCED A CGM ACCURACY ISSUE WHICH OCCURRED THE SAME DAY THE SENSOR WAS INSERTED INTO THE ABDOMEN. ON (B)(6) 2024, THE PATIENT WAS ¿NOT RESPONDING¿ TO HER BOYFRIEND AND STARING STRAIGHT AHEAD. NO CGM OR BG METER VALUES WERE NOTED AT THIS TIME. THE PATIENT¿S BOYFRIEND CALLED EMERGENCY MEDICAL SERVICES (EMS). EMS ARRIVED, AND THE PATIENT¿S BG METER READING WAS 47 MG/DL WHILE THE CGM WAS READING 370 MG/DL. EMS TREATED THE PATIENT WITH UNSPECIFIED IV FLUIDS AND GLUCOSE. THE PATIENT DECLINED EMS¿ OFFER TO TAKE HER TO THE EMERGENCY ROOM. THE PATIENT WANTED TO ¿SLEEP IT OFF¿. THE PATIENT WAS STILL NOT FEELING WELL AT THE TIME OF REPORT. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED. 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 FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE A 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
    670365 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other