BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 25172760 · Received May 14, 2026

    Report

    Report Number
    3004753838-2026-151521
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 14, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPERGLYCEMIA AND LOSS 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. ON (B)(6) 2026 AROUND 02:00 AM, THE PATIENT AWOKE DUE TO VOMITING AND EXPERIENCED REPEATED LOW ALERTS, AND THE CGM READING WAS LOW AND IN THE 40 MG/DL RANGE. RELYING ON THE CGM READINGS, THE PATIENT ATTEMPTED TO TREAT LOW READING BY DRINKING JUICE AND FLUIDS WITH SUGAR FOR OVER SEVERAL HOURS. DESPITE CONTINUED INTAKE, THE CGM PERSISTENTLY DISPLAYED LOW AND IN THE 40 MG/DL RANGE. LATER IN THE MORNING, AT APPROXIMATELY 07:00 08:00 AM, DUE TO CONTINUED CGM LOW READINGS AND SYMPTOMS, THE PATIENT USED A GLUCAGON NASAL SPRAY, WHICH CAUSED AN INTENSE HEADACHE. THE PATIENT BECAME SICK WITH ONGOING VOMITING, DEHYDRATION, WEAKNESS, INCREASED THIRST, AND EVENTUALLY PASSED OUT. THE PATIENT´S FRIEND CONTACTED EMERGENCY MEDICAL SERVICES (EMS) AFTER UNSUCCESSFULLY ATTEMPTING TO REACH THE PATIENT FOR APPROXIMATELY ONE AND A HALF HOURS. NO FINGERSTICK WAS TAKEN AT THAT TIME YET. WHEN EMS ARRIVED AROUND 02:00 PM, A FINGERSTICK WAS TAKEN AND THE GGM READING WAS LOW, AND THE BLOOD GLUCOSE READING WAS HI. THE CGM DEVICE WAS REMOVED. THE PATIENT WAS IN AND OUT DURING TRANSPORT AND WAS GIVEN INTRAVENOUS FLUIDS AND INSULIN. UPON ARRIVAL AT THE LOCAL EMERGENCY ROOM, THE BLOOD GLUCOSE READING WAS 1400 MG/DL. THE PATIENT WAS DIAGNOSED WITH HEART ATTACK BUT DENIED OFFICIAL DIAGNOSIS WITH DIABETIC KETOACIDOSIS. THE PATIENT WAS IMMEDIATELY AIRLIFTED VIA HELICOPTER TO AN INTENSIVE CARE UNIT (ICU) IN A DIFFERENT HOSPITAL. THE PATIENT REGAINED FULL CONSCIOUSNESS IN THE SECOND HOSPITAL DAY. HOSPITAL FINDINGS INCLUDED SEVERE HYPERGLYCEMIA. THE PATIENT WAS ADMITTED TO THE ICU FOR APPROXIMATELY 6 DAYS AND ANOTHER DAY IN A REGULAR ROOM. AT THE TIME OF THE REPORT THE PATIENT WAS STABLE. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR WHEN THE PATIENT HAD SYMPTOMS. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID WHEN EMS ARRIVED. 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 ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566153 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other| H INSULIN PUMP.| MEDICATION.