BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 21538103 · Received March 6, 2025

    Report

    Report Number
    3004753838-2025-053952
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    February 12, 2025
    Report Date
    March 6, 2025
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000866
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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) 2025, IT WAS REPORTED THAT AT 8 PM, THE PATIENT EXPERIENCED VOMITING AND THE CGM READING WAS LOW. AN AMBULANCE WAS CALLED AND THE PARAMEDICS ARRIVED AND DIAGNOSED THE PATIENT WITH DKA. THE BG READING WAS 20 MG/DL (WHICH WOULD NOT BE CONSISTENT WITH A DIAGNOSED DKA). THIS WAS ASKED TWICE ON THE CALL FOR READINGS AS THE PATIENT INSISTED, HE WAS EXPERIENCING DKA WHILE HAVING LOW READINGS. ONE SENSOR WAS USED FOR THE INITIAL/PARAMEDICS EVENT ON 2025-02-12, WHEN THE PATIENT WAS RUSHED TO THE HOSPITAL (250225-006523/SENSOR 1), AND ANOTHER SENSOR (OR SENSOR 2 - 2250225-008315) WAS USED ON 2025-02-13 FOR TESTS WHILE THE PATIENT WAS ALREADY IN THE HOSPITAL FOR DKA TREATMENT. THE PATIENT TREATED WITH VITAMINS, NUTRIENTS, AND IV FLUIDS. DESPITE THE TREATMENT, THE PATIENT'S CONDITION DID NOT IMPROVE. AT AROUND 9:30 PM, THE PARAMEDICS DECIDED TO TRANSPORT THE PATIENT TO THE HOSPITAL. DURING THE AMBULANCE RIDE, THE SENSOR WAS REMOVED, BUT THE DEXCOM CONTINUED TO SHOW LOW READINGS, AND BGM READINGS REMAINED AT 20 MG/DL OR LOWER. THE SENSOR WAS REMOVED FOR THE FIRST TIME DURING THE AMBULANCE RIDE, POSSIBLY FOR TESTING OR PROCEDURES. ON (B)(6) 2025, THE CGM READING WAS APPROXIMATELY 400 MG/DL, AND BGM READINGS WERE AROUND 426 MG/DL (DOCUMENTED IN (B)(4)). THE PATIENT WAS ASKED TO REMOVE THE SENSOR FOR THE SECOND TIME FOR FURTHER TESTS OR PROCEDURES. THE PATIENT WAS DISCHARGED AND RECOVERED AROUND (B)(6) 2025, THE CGM READING WAS 317 MG/DL AND THE BG READING WAS 352 MG/DL. THE PATIENT WAS TREATED WITH VITAMINS AND MINERALS AND WAS ADVISED BY HIS DOCTOR TO FOLLOW UP. THE PATIENT MENTIONED HE WAS STILL IN THE HEALING PROCESS, DEALING WITH A BUSTED TAILBONE, LEG DAMAGE, AND OTHER STOMACH PROBLEMS (NOT RELATED TO DEXCOM). DATA WAS RECEIVED BUT DOES NOT REFLECT FULL INVESTIGATION WINDOW. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. WHEN THE PARAMEDICS CAME, THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. ON (B)(6) 2025, THE REPORTED GLUCOSE VALUES FALL WITHIN THE A ZONE OF THE PARKES ERROR GRID. ON (B)(6) 2025, THE REPORTED GLUCOSE VALUES 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
    798767 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9535-77 7330432 00386270000866

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Hospitalization| O INSULET OMNIPOD5