BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 12096984 · Received June 30, 2021

    Report

    Report Number
    3004753838-2021-117456
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 16, 2021
    Report Date
    June 30, 2021
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    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) 2021. ON (B)(6) 2021, THE PATIENT STATED THAT THE SENSOR WAS GIVING HIM INCORRECT READINGS (VALUES NOT PROVIDED), SO HE TREATED HIMSELF WITH INSULIN. THE CGM READING WENT BELOW 4.0 MMOL/L SO HE CHECKED HIS BG AND IT WAS 33.3 MMOL/L. HE FELT THAT HE WAS NEARING A COMA, SO HE WENT TO THE EMERGENCY ROOM. HIS BG AT THE HOSPITAL WAS 40 MMOL/L. HE WAS GIVEN FOUR BAGS OF IV FLUIDS FOR HEMODILUTION, AND AN INSULIN DRIP. HE WAS RELEASED FROM THE HOSPITAL THE SAME DAY (STATED AS ¿LAST NIGHT¿ WHEN HE CALLED THE DAY AFTER THE EVENT). AT THE TIME OF THE REPORT THE NEXT DAY HE WAS FEELING NORMAL. NO DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D 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
    986777 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other