BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITOR

    MDR report key: 3820415 · Received May 15, 2014

    Report

    Report Number
    MW5036140
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 26, 2014
    Report Date
    May 5, 2015
    Manufacturer
    DEXCOM
    Product Code
    MDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A SEVERE EPISODE OF HYPOGLYCEMIA. I HAVE BEEN WEARING THE DEXCOM G4 PLATINUM CONTINOUS GLUCOSE MONITOR SINCE (B)(6) 2014. WORKING WITH MY DR'S NURSE. THE RECEIVER WHICH MAKES THE SOUND WAS SENT BACK TO DEXCOM ON WEDNESDAY (B)(6) 2014. HYPOGLYCEMIA EVENT -PARAMEDICS CALLED-DEXTROSE IV GIVEN AT HOME -TRANSPORTED TO ER. DIABETES EDUCATOR. I GET UP THE "PROFILE" TO WARN ME OF HIGH BLOOD SUGAR AT 240 MG/DL. LOW GLUCOSE WARNING WAS SET FOR WARNING AT 95 MG/DL. TYPE OF WARNING WAS SET ON "ATTENTIVE" WHICH IN ADDITION TO BUZZES ADDS A MELODY OF NOTES. I WAS IN MY PAINTING STUDIO AND MUST HAVE STARTED TO GO LOW. MY WIFE FOUND ME AT 6:00 PM ON THE KITCHEN FLOOR, UNCONSCIOUS. I HAVE NO MEMORY AFTER I SAT DOWN AT 3:15 PM AT MY WORK TABLE. MY WIFE GAVE ME GLUCAGON INJECTION AND CALLED 911. EMT HAD DIFFICULT TIME STARTING A LINE FOR IV DEXTROSE. TOOK 20 MINS BECAUSE I WAS SO DEHYDRATED. TRANSPORTED TO (B)(6). BLOOD WORK SHOWED LOW SODIUM. RELEASED 4 HOURS LATER. AFTER COMING HOME, MY WIFE CHECKED THE DEXCOM G4 PLATINUM AND FOUND THAT THE MELODY SOUNDS -WARNING ME OF LOW OR HIGH BLOOD SUGAR WERE NOT WORKING AT ALL. IT SEEMS THE PROGRAM WHICH SIGNALS THE DEVICE WAS NOT WORKING OR THE SPEAKERS WERE OUT. NO WARNING GIVEN TO ME THAT MY GLUCOSE LEVEL WAS DROPPING. ALSO MY MILD COGNITIVE IMPAIRMENT GETS WORSE WHEN I HAVE HYPOGLYCEMIA -MORE BRAIN CELLS STARVED OF OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292570 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITOR GLUCOSE MONITOR MDS DEXCOM

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| O| R MEGA RED KRILL OIL| DEXCOM G4 CGM| OMEPRAZOLE| ESCITALOPRAM| ONE TOUCH GLUCOSE METER| BAUSCH AND LOMB PRESERVISION VITAMINS W/LUTEIN| SIMVASTION| LABETLE| FOLBEE| LISINOPRIL| MEDTRONIC PARADIGM INSULIN PUMP