BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 20563361 · Received October 29, 2024

    Report

    Report Number
    3004753838-2024-281669
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 29, 2024
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    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 SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2024. THE PATIENT EXPERIENCED A CGM ACCURACY ISSUE WHICH OCCURRED 5 DAYS AFTER SENSOR INSERTION INTO THE ABDOMEN. ON (B)(6) 2024, THE PATIENT HAD BEEN WALKING AROUND A LOT DURING THE DAY AND FELT UNCOMFORTABLE AND "WEIRD". IT WAS NOTED THAT THE PATIENT RECENTLY HAD OPEN HEART SURGERY. THAT EVENING, HE HAD DINNER WITH FRIENDS AND HIS CGM WAS READING 90 MG/DL. NO BG METER COMPARISON WAS TAKEN. THE PATIENT STATED HIS CGM LEVEL IS USUALLY ALWAYS AROUND 90 MG/DL, AND THAT RARELY GOES OVER 100 MG/DL OR UNDER 90 MG/DL. THE NEXT THING THE PATIENT REMEMBERS IS WAKING UP IN THE EMERGENCY ROOM (ER) AROUND 8-9PM. THE PATIENT HAD LOST CONSCIOUSNESS AT SOME POINT DURING HIS DINNER WITH FRIENDS. IN THE ER, HE WAS TOLD HIS BG LEVEL WAS 16 MG/DL. NO CGM COMPARISON WAS REPORTED. THE PATIENT WAS TREATED WITH IV DEXTROSE. AFTER TREATMENT, THE PATIENT¿S BG METER READING WAS AROUND 121-131 MG/DL. THE PATIENT WAS DISCHARGED HOME A FEW HOURS LATER. THE PATIENT WAS OKAY AT THE TIME OF THE REPORT. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WAS NOT A COMPLETE SET OF REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041953 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other