BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9564353 · Received January 8, 2020

    Report

    Report Number
    3004753838-2020-002017
    Event Type
    Death
    Date Received
    January 8, 2020
    Date of Event
    December 12, 2019
    Report Date
    January 27, 2020
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE PATIENT¿S DAUGHTER STATED ON (B)(6) 2019, THE CGM WAS 112 MG/DL, TRENDING DOWN AND THE PATIENT DID NOT FEEL WELL. THE CGM VALUES CONTINUED TO DECREASE TO THE 90S AND 80S MG/DL, AND THE PATIENT STARTED TO EAT TO INCREASE HER BLOOD GLUCOSE. THE PATIENT¿S BG VALUE WAS NOT PROVIDED. THE CGM VALUES CONTINUED TO DECREASE AND EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED. THE PATIENT¿S BG PER EMS WAS ABOVE 500 MG/DL (THE EMS METER DOES NOT READ HIGHER THAN 500 MG/DL). THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND DURING TRANSPORT, THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT WAS REVIVED, ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WITH A BG OVER 1000 MG/DL, TREATED FOR DIABETIC KETOACIDOSIS (DKA), MYOCARDIAL INFARCTION (MI), AND ORGAN FAILURE. IT WAS REPORTED TO DEXCOM ON (B)(6) 2019 THAT NINE DAYS AFTER ADMISSION TO THE HOSPITAL, THE PATIENT DIED AS A RESULT OF ORGAN FAILURE AND MYOCARDIAL INFARCTION. THE SENSOR INSERTION DATE AND LOCATION WERE NOT PROVIDED. DATA WAS EVALUATED AND THE ALLEGATION WAS UNDETERMINED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR, ADDITIONAL INFORMATION WAS OBTAINED ON 01/14/2020. IT WAS REPORTED THAT THE PATIENT COULD NOT DETERMINE WHAT WAS HAPPENING AND WHY SHE WAS FEELING SICK, AND THAT A FEW HOURS LATER SHE WAS FOUND UNCONSCIOUS. NO FINGERSTICK BLOOD GLUCOSE (BG) WAS PERFORMED BY THE USER OR THE FAMILY PRIOR TO THIS EVENT. THE PARAMEDICS WERE CALLED, AND UNSPECIFIED TREATMENT BASED UPON THE CONTINUOUS GLUCOSE MONITOR (CGM) WAS PROVIDED. BECAUSE THE PATIENT WAS NOT RESPONDING TO THE UNSPECIFIED TREATMENT, THE PARAMEDICS PERFORMED A FINGER STICK BG EITHER BEFORE OR WHEN THE PATIENT WAS LOADED INTO THE AMBULANCE. THE BG WAS 500 MG/DL OR HIGHER. THE DATA INVESTIGATION SHOWED NO CALIBRATIONS HAD BEEN ENTERED TO CONFIRM THE REPORTED INACCURACY WITHIN THE INVESTIGATION WINDOW. DUE TO THE LACK OF VISIBILITY OF METER VALUES NOT ENTERED AS CALIBRATIONS, THE ALLEGATION OF INACCURACIES COULD NOT BE CONFIRMED. THE DATA WAS FURTHER INVESTIGATED, AND LOW ALERTS OCCURRED ON THE MOBILE APPLICATION. THE PATIENT PASSED THE LOW THRESHOLD OF 80 MG/DL AT 11:33 AM WITH AN EGV OF 79 MG/DL ON (B)(6)2019. THE PATIENT RECEIVED THE LOW ALERT AT ZERO PERCENT VOLUME AT 11:33 AM THROUGH THE RECEIVER PORT. THE PATIENT RECEIVED THE LOW ALERT AT FIFTY PERCENT VOLUME AT 11:38 AM THROUGH THE SPEAKER PORT. THE PATIENT CONTINUED TO RECEIVE THE LOW ALERT AT ONE HUNDRED PERCENT VOLUME IN FIVE-MINUTE INTERVALS FROM 11:43 AM TO 11:53 AM THROUGH THE SPEAKER PORT. THIS LOW ALERT WAS CLEARED AT 12:13 PM. THE DATA INVESTIGATION SHOWED THAT THE CGM HAD OVER ONE HOUR OF SIGNAL LOSS FROM APPROXIMATELY 12:19 PM TO 1:39 PM AND 1:44 PM TO 4:44 PM ON (B)(6) 2019 AFTER THE REPORTED EVENT TIME. THE PATIENT DID NOT RECEIVE A SIGNAL LOSS ALERT DURING OR AFTER THESE INTERVALS OF SIGNAL LOSS. HOWEVER, THE URGENT LOW, FALL RATE, CALIBRATION REQUESTED, AND LOW ALERTS WERE CLEARED BETWEEN AND AFTER THE TWO PERIODS OF SIGNAL LOSS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26519 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. 9500-27 NI 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| O