BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 24570480 · Received March 11, 2026

    Report

    Report Number
    3004753838-2026-109673
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 11, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270004116
    PMA / PMN Number
    K213919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA 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 WEARABLE WAS INSERTED INTO THE ABDOMEN WHICH IS AN OFF LABEL INSERTION SITE ON (B)(6) 2026. ON THE NIGHT OF (B)(6) 2026, THE PATIENT¿S CGM WAS READING 400 MG/DL. THE PATIENT SELF-TREATED WITH 3 UNITS OF INSULIN PER ROUTINE DIABETES MANAGEMENT. THE PATIENT WAS WEARING A TANDEM INSULIN PUMP. AT AN UNSPECIFIED TIME LATER, THE PATIENT¿S CGM VALUE DROPPED TO 60 MG/DL. THE PATIENT THEN SELF-TREATED WITH ¿SUGAR¿ AND THE CGM INCREASED TO 120 MG/DL. THE PATIENT REPORTED THAT THE ¿CYCLE OF UP AND DOWN READINGS CONTINUED REPEATEDLY UNTIL THE PATIENT LOST CONSCIOUSNESS¿, WHICH WAS AROUND 340AM ON (B)(6) 2026. IT WAS UNKNOWN WHAT THE PATIENT¿S CGM VALUE WAS AT THIS TIME AND NO BG METER COMPARISON VALUE WAS TAKEN. THE PATIENT¿S DAUGHTER CALLED 911. ONCE EMS ARRIVED, THE PATIENT¿S BG METER READING WAS TAKEN AND FOUND TO BE ¿LOW¿ BUT THE SPECIFIC VALUE COULD NOT BE RECALLED. THE PATIENT¿S CGM VALUE AT THIS TIME COULD ALSO NOT BE RECALLED. EMS TREATED THE PATIENT WITH IV GLUCOSE AND AFTER APPROXIMATELY 20-30 MINUTES, THE PATIENT REGAINED CONSCIOUSNESS. AROUND 420AM, THE PATIENT WAS GIVEN A SECOND DOSE OF IV GLUCOSE (D10) AND TRANSPORTED TO THE ER. THE PATIENT¿S BG METER READING INCREASED TO 245 MG/DL. ONCE AT THE ER, THE PATIENT¿S BG METER READING HAD DECREASED BACK DOWN TO 54 MG/DL. NO CGM VALUE WAS PROVIDED AT THIS TIME. MEDICAL STAFF CONTINUED TO PROVIDE THE PATIENT WITH IV GLUCOSE. AROUND 6AM, THE PATIENT¿S BG METER READING WAS 42 MG/DL. IT WAS REPORTED THE PATIENT WAS ¿FUNCTIONAL¿ AGAIN AROUND 10AM. DESPITE A CONTINUOUS IV GLUCOSE INFUSION, THE PATIENT¿S BG METER READINGS FLUCTUATED BETWEEN 338 MG/DL AND ¿LOW VALUES¿ UNTIL 12PM. THE PATIENT REMAINED IN THE ER FOR ANOTHER 4 HOURS AND THEN THE PATIENT LEFT THE ER AGAINST MEDICAL ADVICE WITH ONLY ¿STANDARD MEDICATION PRESCRIBED¿. AT THE TIME OF DISCHARGE, THE PATIENT¿S BG METER READING WAS 180 MG/DL. NO CGM COMPARISON VALUE WAS REPORTED AT THIS TIME. THE PATIENT WAS ¿FINE¿ AT THE TIME OF REPORT. 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. 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
    629953 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-161 1725318002 00386270004116

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female Other INSULIN PUMP