BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22527656 · Received July 16, 2025

    Report

    Report Number
    3004753838-2025-187497
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 16, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000866
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 ARM, WHICH IS OFF-LABEL USAGE OF THE DEVICE ON (B)(6) 2025. THE DATE OF THE EVENT IS AN APPROXIMATION. ON (B)(6) 2025 , THE PATIENT EXPERIENCED RAPIDLY FLUCTUATING CGM READINGS, WITH VALUES DROPPING QUICKLY AND THEN RISING TO ¿HIGH.¿ DURING THIS TIME, THE PATIENT REPORTED SYMPTOMS INCLUDING VOMITING, DISORIENTATION, NAUSEA, DRY MOUTH, AND FREQUENT URINATION. SHE HAD ALREADY ADMINISTERED 7 TO 8 UNITS OF INSULIN PRIOR TO SEEKING MEDICAL CARE. THE PATIENT COULD NOT RECALL THE EXACT CGM READINGS PRIOR TO HOSPITAL ARRIVAL BUT ESTIMATED THEM TO BE BETWEEN 200¿235 MG/DL. AFTER PERFORMING A CALIBRATION, SHE NOTED A DISCREPANCY OF APPROXIMATELY 100 MG/DL BETWEEN THE CGM AND THE BLOOD GLUCOSE (BG) VALUE USED FOR CALIBRATION, THOUGH THE SPECIFIC BG VALUE WAS NOT REPORTED. AT THE HOSPITAL, A BG READING WAS RECORDED AT 498 MG/DL, WHILE THE CGM ESTIMATED GLUCOSE VALUE (EGV) REMAINED AROUND 235 MG/DL. THE PATIENT WAS TREATED WITH INSULIN INJECTIONS AND ADMITTED FOR FURTHER CARE. SHE WAS HOSPITALIZED FOR TWO DAYS. 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 CGM WAS READING "HIGH" AND ESTIMATING BETWEEN 200¿235 MG/DL. IT HAS BEEN REPORTED THAT THERE WAS A DIFFERENCE IN READINGS OF 100 POINTS OFF AFTER CALIBRATING. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID AT THE HOSPITAL. 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
    153369 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9535-77 5368094 00386270000866

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Hospitalization| O