Description of Event or Problem · 1
ON TUESDAY, (B)(6) 2013, I OPENED MY LAST BOX OF MMT-377 INFUSION SETS. FOR MOST OF THE DAY, MY BLOOD SUGAR (BS) WAS HIGH - ABOVE NORMAL. NO AMOUNT OF INSULIN I PUMPED WOULD BRING IT DOWN. I OPENED A NEW INSULIN VIAL, CHANGED INFUSION SETS, AND MOST PARTICULARLY CUT MY FOOD CONSUMPTION IN HALF TO TRY AND CORRECT THE PROBLEM. THE MORNING OF (B)(6), MY BS WAS STILL PROBLEMATIC; I WAS CHECKING MY BS LEVELS HOURLY SO I COULD INJECT INSULIN MANUALLY, IF NECESSARY. AT 11:00AM, I WAS STARTING TO FEEL ILL AND WHEN I CHECKED MY BS, I WAS AMAZED TO SEE A READING OF 400MG/DL. FEELING SICK, I LEFT WORK IMMEDIATELY AND STRUGGLED TO NAVIGATE THE 7 MILE DRIVE HOME. UPON ARRIVAL, I LUNGED INTO THE GARAGE AND VOMITED INTO A GARBAGE BIN. UNFORTUNATELY, A SMALL FOOD PARTICLE LODGED IN MY THROAT AND I WAS UNABLE TO BREATH. MY PARTNER WAS HOME HAD HEARD THE COMMOTION IN THE GARAGE. HE CAME RUSHING OUT AND FOUND ME CHOKING. HE IMMEDIATELY GAVE ME THE HEIMLICH MANEUVER TWICE. MY BREATH RETURNED IN SPURTS AND GASPS. I FELL TO MY HANDS AND KNEES; WAVES OF PAIN GOING DOWN MY BACK SIDES. MY PARTNER GENTLY HELPED ME UP AND LED ME TO THE BEDROOM. I REMOVED THE PUMP ENTIRELY AND GAVE MYSELF 6 UNITS OF INSULIN MANUALLY, AS MY TESTER SUGGESTED. I CONTINUED VOMITING IN OUR BATHROOM UNTIL FINALLY MY PARTNER WAS ABLE TO HELP CLEAN ME UP, AND PUT ME TO BED. THE FIRST TIME I AWOKE 2 HOURS LATER, MY BS WAS STILL 350MG/DL, SUGGESTING TO ME IT WAS PROBABLY SIGNIFICANTLY HIGHER THAN 400MG/DL WHEN I TESTED EARLIER. I TOOK MORE INSULIN MANUALLY AND RETURNED TO BED. I AWOKE 2 HOURS LATER WITH A BS OF 280MG/DL. AT THAT POINT I EXAMINED MY SILHOUETTE SET AND FOUND IT WAS NOT PUMPING ANY INSULIN. I SET THE CLOCK TO GET UP EVERY TWO HOURS AND TAKE MANUAL INSULIN INJECTIONS. THE NEXT DAY, I REPLACED THE RESERVOIR AND INFUSION SET ONCE AGAIN BEFORE GOING TO WORK. MY BS CONTINUED TO BE HIGH (BETWEEN 270 AND 290). AGAIN, I WAS FORCED TO GIVE MYSELF MANUAL INJECTIONS THROUGHOUT THE DAY. I WAS FRUSTRATED, ANGRY AND TIRED. PLUS, I WAS SUFFERING THE EFFECTS OF ERRATIC AND HIGH BS LEVELS (NOTABLY BLURRED VISION, EXCESSIVE THIRST, CONSTIPATION AND GENERAL FEELING OF MALAISE AND DESPAIR). YOUR LETTER, "URGENT MEDICAL DEVICE SAFETY NOTIFICATION" ARRIVED THAT AFTERNOON. FINALLY I KNEW WHAT THE PROBLEM WAS. CALLING THE MEDTRONIC HELP LINE WAS FUTILE. MEDTRONIC REPS DID NOT SEEM TO KNOW ABOUT THE HEALTH WARNING THAT WAS ISSUED AND ALTERNATELY SENT ME, OR FORGOT TO SEND ME, THINGS THEY PROMISED WOULD HELP THIS SITUATION. MOST REPLACEMENT ITEMS, AS WELL AS MY NEXT 3 MONTH ORDER THAT ARRIVED SOON AFTER THIS EVENT, WERE ALL FROM THE SAME LOT NUMBER AS THE PROBLEMATIC ONES. "AREN'T THEY A PROBLEM TOO?" I ASKED. "PROBABLY NOT," SOMEONE FROM YOUR HELP LINE SAID. NOT VERY REASSURING! AT THIS POINT, I WOULD HAVE LIKED TO HEAR, "CERTAINLY NOT." I FIND IT REPREHENSIBLE THAT YOU WOULD PUT ME, AND NO DOUBT MANY OTHERS, IN SUCH JEOPARDY. UPON CALLING THE MEDTRONIC HELP LINE A FRIENDLY VOICE SAYS: "YOUR SAFETY IS OUR CONCERN." CLEARLY, THIS IS NOT THE CASE. ACCORDING TO THE INTERNET, MONEY IS YOUR TOP CONCERN. MEDTRONIC PROFIT IS IN THE BILLIONS OF DOLLARS. IS THIS IN PART DUE TO YOUR DISREGARD OF HUMAN SAFETY AND UNWILLINGNESS TO FOLLOW INDUSTRY STANDARDS? PERHAPS MEDTRONIC SHOULD SPEND SOME OF ITS VAST WEALTH ON BETTER QUALITY CONTROL. THE END OF YOUR WARNING LETTER SAYS: "THANK YOU FOR YOU CONTINUED TRUST IN MEDTRONIC." PLEASE UNDERSTAND: YOU DO NOT HAVE MY TRUST. I HAVE HAD MORE TROUBLE WITH THIS PUMP THAN THE 4 OR SO PUMPS I HAVE HAD PREVIOUSLY. THE WORST THING ABOUT MY ORDEAL WAS NOT MISSING WORK, OR FEELING THE HUMILIATION OF BEING HELPED FROM A DIRTY GARAGE FLOOR, NOR WAS IT THROWING UP IN A TRASH CAN, OR NEEDING ASSISTANCE TO CLEAN MYSELF UP. SECONDARY WAS THE HIGH FINANCIAL COST OF THE SUPPLIES NEEDED TO COPE WITH THIS INCIDENT (INSULIN, RESERVOIRS, INFUSION SETS, NEEDLES, SANITARY WIPES, BATTERIES, ADHESIVE, ETC), AS WAS MISSING WORK, THE TIME AND DISCOMFORT OF TESTING BS LEVELS EVERY HOUR, OR USING MULTIPLE TEST STRIPS IN EXCESS OF (B)(4) EACH, OR THE DISCOMFORT OF GIVING MYSELF MANUAL INSULIN INJECTIONS. RATHER, IT WAS A PHYSICAL PAIN THAT IS DIFFICULT TO DESCRIBE; PAIN AND DISCOMFORT, EXHAUSTION, DIFFICULTY SEEING, THE PAIN OF MOVING MY ARMS AND LEGS AND IN MY CHEST, THE RELENTLESS ITCHING AT THE BACK OF MY ARMS FROM SHOULDER TO ELBOW AND IN MY SHINS FROM MY KNEES TO MY ANKLE. ADDITIONALLY, THE EMOTIONAL PAIN OF THIS EPISODE WAS UNTENABLE: WONDERING IF THIS IS HOW IT FEELS TO DIE? ASKING MYSELF IF I WOULD WAKE UP SHOULD I FALL ASLEEP. WONDERING IF I WOULD SURVIVE THIS EPISODE AND, IF SO, WOULD THE LENGTH AND QUALITY OF MY LIFE, MY EYESIGHT, AND/OR MY BALANCE BE COMPROMISED? ON MY MIND TOO WAS THE GUILT OF KNOWING THAT I SHOULD NOT HAVE DRIVEN A CAR WHILE SO SICK; THAT I COULD HAVE EASILY HURT SOMEONE ELSE. AND OF COURSE, THERE WAS THE QUESTION OF "WHAT WOULD HAVE HAPPENED IF I HAD VOMITED IN THE CAR AND CHOKED?" FINALLY, THERE WAS A VERY REAL CONCERN THAT I WAS PROBABLY NOT THE ONLY PERSON WHO HAD AN ORDEAL LIKE THIS ONE. THERE MUST HAVE BEEN OTHERS WHO ALSO SUFFERED, OR WILL SUFFER, HIGH BLOOD SUGAR LEVELS AND ITS CONCOMITANT CONSEQUENCES DUE TO THIS ERROR. I AM ANGRY AND UPSET AND IF MY LETTER SOUNDS CONTEMPTUOUS IT HAS HIT THE MARK. IT IS NOT OK TO PLAY WITH MY LIFE AND THE LIVES OF SO MANY OTHERS. NOT KNOWING STILL IF THE PRODUCT I NOW HAVE IS SAFE IS UNNERVING. I FEEL LIKE A GUINEA PIG. IT IS MY OPINION THAT MEDTRONIC IS AN INEPT AND DANGEROUS CORPORATE CITIZEN. I AM EMBARRASSED TO SAY THAT I WEAR ONE OF YOUR PRODUCTS AND MUST DO SO UNTIL SUCH TIME AS I CAN AFFORD A REPLACEMENT. WHEN THAT HAPPENS, I WILL NOT LOOK TO YOU TO GET HELP. IT IS MY SINCERE HOPE THAT OTHERS WILL FOLLOW SUIT AND THAT THE MEDICAL COMMUNITY WILL STOP PROMOTING YOUR DANGEROUS PRODUCTS.