BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM SEVEN PLUS CGMS

    MDR report key: 2348578 · Received November 20, 2011

    Report

    Report Number
    MW5023194
    Event Type
    Injury
    Date Received
    November 20, 2011
    Date of Event
    November 17, 2011
    Report Date
    November 20, 2011
    Manufacturer
    DEXCOM
    Product Code
    MDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM REPORTER (B)(6) 2011: ERRATIC - INTERMITTENT BEHAVIOR OF A SECOND SENSOR FROM SAME BATCH AFTER 6 DAYS OPERATING. SENSOR DROPPED ITS READINGS TWICE IN SPEED AND PATTERN NOT CONSISTENT WITH BODY OPERATION. JUST AFTER 12:00 AM MIDNIGHT SENSOR DROPPED FROM 150 TO 135 IN A FAST DROOP. AS TIME PROGRESSED TO 2:00 AM READING JUMPED BACK TO ABOUT 160. JUST AFTER 3:00 AM, SENSOR READING DROPPED RAPIDLY TO 100 FROM 160 AND STAYED OSCILLATING AROUND 100 AND BEFORE 4:00 AM DROPPED BELOW 100 TO 85 AND THEN POPPED BACK TO 150 BY 4:00 AM. I GENTLY PRESSED DOWN ON SENSOR AT 5:00 AM A COUPLE OF TIMES AND SENSOR CONTINUED TO WORK MORE NORMALLY. FREE STYLE LIGHT FINGERSTICK MACHINE REGISTERED 136 AT 5:25 ON LEFT HAND AND AT 5:26 REGISTERED 139. I AVERAGED READING AND ENTERED 138 TO DEXCOM BG ENTRY. IN ALMOST 10 MONTHS USE AND EXCEPT FOR LAST SENSOR - NEW BATCH WHICH FAILED IN SIMILAR WAY IN ONE DAY FLAT WITH SILICON GREASE - ASSUME - ALL LOOSE INSIDE SENSOR PLATFORM AND COATING ELASTOMER CONNECTORS, I HAVE NOT SEEN THIS BEHAVIOR BEFORE EXCEPT AS NOTED. I HAVE NOT HAD CHANGE TO REMOVE TRANSMITTER IN SITU TO CONFIRM SILICON GREASE CONTAMINATION BUT ASSUME SINCE BEHAVIOR OF LAST SENSOR AND THIS SENSOR IDENTICAL, PROBLEM IS PROBABLY THE GREASE. REPORTED TO DEXCOM - NO RESPONSE ON EITHER SENSOR. I RELY ON UNITS READINGS TO PREVENT MY BG DROPPING SUB 100 TO PREVENT MAJOR LIVER OVERDUMP OF GLUCOSE IN ERROR BY LIVER. ERRATIC PERFORMANCE INTERFERES WITH MY SAFETY. LIVER ON DUMP SHOOTS BG UP TO 511 AND SLIDES BACK TO 278 AS HEART PUMPING MIXES UP THE GLUCOSE ALL AROUND THE BODY. ADDITIONAL INFO RECEIVED FROM REPORTER (B)(6) 2011: WHENEVER UNIT GETS NOT IN A WARM ENVIRONMENT - 80 DEGREES F, RECEIVER STALLS AND REPORTS CONSTANTLY A BG VALUE USUALLY 164 IRREGARDLESS OF ACTUAL READING. WORK AROUND HAS BEEN TO MOUNT RECEIVER IN PLASTIC STORAGE BOX THAT ENCLOSES INSULATION AND A COLD CHILL PACK. UNIT THEN PERFORMS 24/7 WITHOUT INCIDENT AS LONG AS IT IS KEPT COOL. THIS PROBLEM WAS REPORTED TO FDA BACK IN (B)(6) 2011, AFTER I HAD TRIED A SECOND UNIT WHICH DISPLAYED SAME OPERATION. FDA REQUESTED I GET THIRD UNIT AND DEXCOM HAS REFUSED TO SEND ONE OR ACKNOWLEDGE PROBLEM NOR CONFIRM THEY TEST PRODUCTS IN OVEN TO ENSURE RELIABLE OPERATION AT ELEVATED TEMPERATURES. THE ONLY WAY I CAN GET RELIABLE OPERATION AND HAVE DONE SO FOR LAST 8 MONTHS AND STILL DO TODAY IS KEEP RECEIVER COOLED. MY GOAL PER MY DOCTOR'S ORDERS IS TO PREVENT BG DROPPING SUB 100 SO AS NOT TRIGGER A LIVER GLUCOSE ADD CYCLE SINCE MY LIVER ALWAYS DUMPS FULL LIVER LOAD AND SHOOTS BG TO 511 AND THEN SLOWLY DECAYS TO 278 AS HEART PUMPS GLUCOSE AROUND MY LARGE BODY. CONTROLLING MY LIVER HAS ALLOWED ME TO GET MY A1C DOWN FROM 13.3 TO 6.4 AND STOP BODY ROT, KIDNEY DEGRADATION STOPPED. THE CGMS PROPERLY WORKING ALLOWS ME TO MANAGE BY BG SO IT DOES NOT GO TOO LOW AND TRIGGERING THIS EVENT. SEE MY BOOK AT THE PRECIPICE BY (B)(6) MY CASE AND ISSUES. I BELIEVE THAT AS CITIZEN OF USA (B)(6), I SHOULD BE ABLE TO GET PROPERLY WORKING MEDICAL EQUIPMENT WITHOUT UNEXPLAINED INACTION AND STALLING. I AM REQUESTING FDA PLEASE SORT THIS MESS OUT AND SEE THAT I GET PROPERLY WORKING EQUIPMENT AND SENSORS FROM THIS COMPANY. FOLLOW ON EVENT ON PREVIOUS REPORT: I FORGOT TO MENTION THE SENSOR BATCH WHICH IS (B)(4); LOT: 5023981 AND DATE OF (B)(6) 2012. (B)(6) AT MIDNIGHT, SENSOR READING SUDDENLY DROPPED FROM 150 TO 116 AROUND MIDNIGHT. FREESTYLE LIGHT READINGS WERE IN THE 150. PRESSING THE SENSOR SEEMED TO CAUSE THE READINGS TO GO BACK STABLE AND REMAIN THAT WAY UNTIL SENSOR STOPPED ON (B)(6). (B)(6) WAS TIME TO REPLACE/RESTART AFTER 7 DAYS. I NOTE THE FOLLOWING: AFTER STOPPING SENSOR AND INSPECTING; I FOUND THE WHOLE RIGHT SIDE OF THE SENSOR ATTACHMENT ADHESIVE RELEASED. I TAPED IT DOWN AND TRIED TO REMOVE TRANSMITTER, INSPECT SENSOR PLATFORM IN SITU. THAT WAS NOT SUCCESSFUL AFTER THE MONKEYING AROUND - I DID NOT EXPECT IT TO DO SO AND AFTER RESTARTING, GOT SENSOR ERROR. INSPECTING THE SENSOR PLATFORM ALSO SHOWED A GREASE SUBSTANCES IN THE WELL AND UNDER THE SENSOR WIRE CONNECTION PLATE. THE SENSOR ADHESIVE ATTACHMENT MATERIAL HAD NO STICKINESS WHATSOEVER AND LOOKED STAINED FROM MELTING GREASE OF SENSOR PLATFORM THAT HAD DRAINED ONTO IT. I CAREFULLY CLEANED MY ARM AND INSTALLED A NEW SENSOR. WHEN I INSTALLED THE SENSOR PLATE AS PER INSTRUCTIONS, I NOTICE THAT THE SENSOR CONNECTION PLATE SITS UP AT AN ANGLE UNTIL TRANSMITTER SEATED. I FOUND GREASE INSIDE THE PLATFORM AND CAREFULLY WIPED UP/REMOVED THE GREASE IN THE WELL AND THE SENSOR PLATE - TOP AND BOTTOM. I THEN CAREFULLY CLEANED THE BACK OF THE TRANSMITTER AND CAREFULLY INSTALLED ON THE SENSOR PLATFORM. AFTER 2 HOURS THIS NEW SENSOR STARTED UP WITHOUT INCIDENT. OTHER THAN SENDING OCCASIONAL BAD SENSORS, MAJOR DEFICIENCIES NOT RESOLVED NOR RESPONDED TO. PT HAS TO DO THE FOLLOWING WORKAROUNDS TO ENSURE RELIABLE OPERATION AS FOLLOWS: LATEST WORKAROUNDS: GREASE USED ON SENSOR PLATFORM MELTS ON BODY TEMPERATURE AND FLOWS ALL AROUND SENSOR PLATFORM, COATING TRANSMITTER BOTTOM SIDE AND CONTACTS AS WELL AS LEAKING OUT BOTTOM AND DEFEATING SENSOR ADHESIVE ATTACHMENT PAD CAUSING IT TO RELEASE PRE-MATURELY. WORK AROUND IS TO CAREFULLY CLEAN OUT EXCESSIVE GREASE WITH Q TIPS PRIOR TO INSERTING TRANSMITTER. ALSO THE SENSOR WIRE CONNECTING PLATE IS ANGLED UP PRIOR TO INSTALLATION OF TRANSMITTER ENABLING CLEANING UNDERSIDE OF THE CONNECTOR PLATE AND THE SENSOR WELL IT COVERS. DEXCOM ASKED - NO RESPONSE. LEAKAGE OF GREASE CAUSES ELASTOMER CONNECTORS OF LOW VOLTAGE/LOW CURRENT SENSOR SIGNAL TO GO INTERMITTENT. WORKAROUNDS SINCE PURCHASE (B)(6) 2011: RECEIVER CHIPS SEEM TO OVERHEAT IN WARM BUILDING AND STALL AND SHOW SAME OLD DATA WITHOUT INTERRUPTING. CHILLING RECEIVER CAUSES IT TO GO BACK WORKING CORRECTLY. WORKAROUND IS TO MOUNT RECEIVER ON A FOOD STORAGE BOX WITH REMOVABLE FLUID THAT ENABLES MOUNTING A SEALED CHILL PACK THAT KEEPS RECEIVER COOLED. DOING THIS ENABLES 24/7 RUN TIME WITHOUT STALLS AND BAD DATA. SEVEN UNIT SENT FROM DEXCOM FAILED AS WELL. FDA CONTACTED - THEY STATED GET THIRD UNIT. DEXCOM REFUSED TO SEND THIRD UNIT NOR REPAIR. CONTINUE TO RUN ON CHILLPACK. LOW LEVEL ALARM OF 100 TO LOW; SO I NEED TO MANUALLY WATCH ALL THE TIME TO CATCH BG SHOULD IT GET TO 120 AND THEN I ADD GLUCOSE CANDY, FOOD TO PREVENT BG GOING TO LOW AND TRIGGERING LIVER DUMP. BEING ENABLE TO SET 120 WOULD BE A GODSEND AND EXCELLENT HELP. RF REFERENCE CAUSES RECEIVER TO STAY STUCK ON THE LAST VALID READING IT GOT BEFORE INTERFERENCE. NO INDICATION GIVEN TO USER THAT RECEIVER IS JAMMED/INTERFERED WITH. WORK AROUND IS TO WATCH DISPLAY OF RECEIVER AND IF THE DISPLAY GOES SUPER FLAT LINE, GET FINGERSTICK MACHINE ON JOB AND CROSS CHECK. IF READING DIFFERENCE THEN MOVE TO ANOTHER AREA OR BEHIND A FRIDGE; LARGE MASS OF METAL TO BLOCK INTERFERER. ALSO, OVERHEAT CONDITION IS ALSO DETECTED THE SAME WAY EXCEPT ON MY UNIT AN OVERHEAT SEEMS JAMMED ON THE SAME VALUE - 164. I DO NOT THINK PT SHOULD HAVE TO WORK AROUND MEDICAL EQUIPMENT "DECIECIENCES" TO COME UP WITH WORK AROUND TO GET USEFUL RELIABLE OPERATION. MY GOAL AT ALL TIMES IS TO CATCH BG BEFORE IT GETS TOO LOW BELOW 120 SO I CAN ADD GLUCOSE, CANDY, FOOD TO PUSH BACK UP AND BLOCK LIVER DUMPS. SEE MY BOOK AT (B)(6) THAT DETAILS MY CASE AND DIABETES. ADDITIONAL INFO RECEIVED FROM REPORTER (B)(6) 2011: LOW LEVEL ALARM SET CAN ONLY BE SET TO 100. THIS IS TOO LOW. MY DOCTOR HAS ORDERS THAT REQUEST NOT ALLOWING NG DROPPING LESS THAN 100 TO PREVENT A LIVER DUMP ON MY FAULTY LIVER. I HAVE TO CATCH BG BY TIME IT IS 120 TO ADD SOME GLUCOSE, FOOD, CANDY ETC TO ARREST FALL OF BG. DEVICE DELAY OF 10 MINUTES PLUS INTERSTITIAL DELAY ARE SUCH THAT IF I RELY ON MIN ALARM AT 100, BG ON MY BIG BODY IS MOVING FAST AND WILL BE SUB 80 BEFORE I CAN ARREST. I NEED TO START AT 120 TO OVERCOME DELAYS. MY LIVER DUMPS EXCESSIVE GLUCOSE ON DUMP, DUMPING FULL LIVER LOAD IRREGARDLESS OF INSULIN LEVELS IN BG. KEEPING BG AT 6.4 RATHER THAN 13.3 IS ONLY POSSIBLE BY CONTROLLING BG LEVELS AND PREVENTING LIVER DUMPS. MY LIVER DUMPS TO 511/HI IN BG AND THEN SLIDES BACK TO 278 AS HEART PUMPS (B)(6) AROUND BODY DILUTING IT.

    Description of Event or Problem · 1

    ERRATIC - INTERMITTENT BEHAVIOR OF A BRAND NEW DEXCOM SENSOR. INTERMITTENT ERRORS INITIALLY AND THEN LATER READ VALUE COLLAPSED INSTANTLY FROM 150 TO 100 AND REPEATED EVERY 30 MINUTES WHILE READINGS ON A FREE STYLE LIGHT FINGERSTICK MACHINE REMAINED STABLE AND AS EXPECTED. REMOVAL OF SENSOR FOUND A CONTAINMENT OF SILICON GREASE THAT HAD MELTED AND COATED THE ELECTRICAL CONNECTORS OF SENSOR. AFTER CLEANING BACK OF TRANSMITTER CAREFULLY AND INSTALLING A NEW SENSOR, READINGS WERE STABLE AND OPERATING CORRECTLY. I RELY ON STABLE READINGS TO PREVENT BG DROPPING SUB 100 PER DOCTOR'S ORDER TO PREVENT LIVER DUMPS THAT THE LIVER CAUSES BG TO PUMP TO 511 AND SLUMP BACK TO 278 AND HAS BEEN RESPONSIBLE FOR MY INSULIN RESISTANCE AND BODY ROT. I BELIEVE THAT USE OF LUBRICANT THAT MELTS AT BODY TEMPERATURE AND OF SUFFICIENT QUANTITY TO COAT BACK OF TRANSMITTER MODULE AND COATING ELASTOMER CONNECTIONS AND CAUSING INTERRUPTION OF THE LOW VOLTAGE - LOW CURRENT SENSOR WIRES TO THE SOLDER TERMINALS OF THE TRANSMITTER IS JEOPARDIZING MY HEALTH AND CAUSING UNWARRANTED AND DANGEROUS RESPONSE. WHO WAS IDIOT THAT AUTHORIZED THIS USE AND APPLICATION OF LOW TEMPERATURE SILICON GREASE AND QUANTITY RESULTING IN UNPREDICTABLE AND DANGEROUS OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXCOM SEVEN PLUS CGMS CGMS MDS DEXCOM SEVEN PLUS 8219-15 5013511

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| S DOSES| FREE STYLE LITE FINGERSTICK GLUCOSE MONITOR USED| FOR CROSS CHECKING AND FOR ESTABLISHING INSULIN