BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8784450 · Received July 12, 2019

    Report

    Report Number
    3004753838-2019-053302
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    July 4, 2019
    Report Date
    July 12, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270000255
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INACCURACIES BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND BLOOD GLUCOSE (BG) METER. DATE OF ISSUE IS AN APPROXIMATION. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2019. THE PATIENT¿S WIFE STATED THE CGM DISPLAYED 67 MG/DL; HOWEVER, SHE FOUND HER HUSBAND DIAPHORETIC AND UNRESPONSIVE WITH HIS MOUTH CLAMP CLOSED. EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED BECAUSE SHE WAS UNABLE TO PROVIDE ORAL TREATMENT. PER EMS, THE PATIENT¿S BG WAS 40 MG/DL; EMS STARTED INTRAVENOUS (IV) THERAPY AND ADMINISTERED TWO DOSES OF DEXTROSE. POST-EMS TREATMENT, THE PATIENT¿S BG PER EMS WAS 77 MG/DL; HOWEVER, THE CGM DISPLAYED 47 MG/DL AND DID NOT ALERT. THE PATIENT WAS TREATED AT HOME BY EMS AND WAS NOT TRANSPORTED TO THE HOSPITAL. PRIOR TO THE EVENT, THE PATIENT ADMINISTERED 4 UNITS OF INSULIN AFTER DINNER (5:00 PM). AT APPROXIMATELY 10:00 PM, THE PATIENT'S CGM DISPLAYED 75 MG/DL AND THE PATIENT'S WIFE GAVE HIM AN OATMEAL CAKE BECAUSE HE WAS PRONE TO SUDDEN DROPS IN BLOOD GLUCOSE. SHE LEFT THE ROOM AND WHEN SHE RETURNED APPROXIMATELY 30 MINUTES LATER, SHE FOUND HIM UNRESPONSIVE. AT THE TIME OF CONTACT, THE PATIENT WAS IN STABLE CONDITION. DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE ALLEGATION AND A PROBABLE CAUSE COULD NOT BE DETERMINED. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR FOR THE TIME OF THE EVENT. THE DATA INVESTIGATION DID NOT FIND BLOOD GLUCOSE CALIBRATION VALUES TO COMPARE TO CGM VALUES DURING THE REPORTED SENSOR SESSION. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577957 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-45 5253659 00386270000255

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other