Description of Event or Problem · 1
I AM CONTACTING YOU AND YOUR COMPANY IN REGARDS TO AN INCIDENT ATTRIBUTABLE TO YOUR DEFECTIVE PRODUCT THE DELTEK COZMO INSULIN PUMP, (B)(6). ON (B)(6) 2010, I PICKED MY KINDERGARTENER UP FROM SCHOOL AT (B)(6) AT 3:30 PM AND PROCEEDED TO DRIVE TO MY MOTHER IN LAW'S HOUSE (A DISTANCE OF APPROX 12 MILES). UNBEKNOWNST TO ME, THE SMITH-MEDICAL DELTEK COZMO INSULIN PUMP, (B)(6) WHICH I RELIED UPON HAD MALFUNCTIONED. ACCORDING TO THE DIABETIC PUMP SPECIALIST, MY ENDOCRINOLOGIST AND OTHERS, IT IS MOST LIKELY THAT I WAS INFUSED WITH ALMOST DOUBLE INSULIN DOSAGE PROGRAMMED. THIS MALFUNCTION CAUSED MY BLOOD SUGAR TO DROP RAPIDLY. THIS FAILURE PUT MY LIFE, MY CHILD'S LIFE AND THE LIVES OF COUNTLESS OTHER MOTORISTS IN THE (B)(6), IN GRAVE DANGER. MY NEXT MEMORY INVOLVES REGAINING CONSCIOUSNESS IN THE BACK OF AN AMBULANCE. APPARENTLY, A RANDOM STRANGER ON THE HIGHWAY HAD REPORTED ME AS A DRUNK DRIVER. SHE/HE CONTINUED TO FOLLOW ME A SHORT DISTANCE DURING WHICH TIME SHE/HE HAD INFORMED THE 911 OPERATOR OF MY APPROXIMATE LOCATION IN ORDER FOR THE POLICE TO INTERCEDE. POLICE OFFICERS ARRIVED ON THE SCENE, ONE OF WHOM RAN NEXT TO MY CAR AND AT GREAT, PERSONAL RISK TO HIMSELF DOVE INTO MY VEHICLE AND SHIFTED THE CAR INTO "PARK" SINCE I WAS UNCONSCIOUS AND UNABLE TO DO SO. THE EMERGENCY MEDICAL TECHNICIANS WHO SUBSEQUENTLY ARRIVED AT THE SCENE DOCUMENTED MY BLOOD SUGAR AT 24. ASTUTELY, THE EMT STOPPED MY INSULIN PUMP, AND ADMINISTERED TWO TUBES OF ORAL GLUCOSE AND 1 AMP OF D50 HAD TO BE INTRAVENOUSLY ADMINISTERED TO ME IN ORDER TO BRING MY BLOOD SUGAR UP TO A LEVEL WHERE I WAS ABLE TO IDENTIFY MYSELF AND TO RESPOND RELIABLY TO THE PARAMEDIC'S QUESTIONS. AFTER THIS IN-FIELD EMERGENCY ADMINISTRATION OF DRUGS TO COUNTER-ACT THE OVERDOSE OF INSULIN MY SMITH-MEDICAL'S "DELTEK COZMO INSULIN PUMP, (B)(6) HAD INDUCED, I WAS TRANSPORTED TO THE EMERGENCY ROOM. I ARRIVED AT THE HOSP, MY BODY UTTERLY DRENCHED IN SWEAT AND FEELING VERY, VERY LUCKY TO BE ALIVE. IT CANNOT GO WITHOUT BEING SAID THAT YOUR DEFECTIVE PRODUCT POSED A THREAT NOT ONLY TO MY OWN PHYSICAL HEALTH AND WELL BEING BUT ALSO POSED A SIGNIFICANT DANGER TO MY CHILD IN THIS SITUATION. I HAVE BEEN PHYSICALLY AND PERSONALLY SHAKEN BEYOND BELIEF AS A RESULT OF HAVING UNDERGONE SUCH A FRIGHTENING EXPERIENCE ALL DUE TO THE FAILURE OF YOUR PRODUCT TO PERFORM PROPERLY. THE EMERGENCY ROOM DOCTOR BELIEVED MY PUMP TO BE THE SOURCE OF THE ABNORMALLY LOW BLOOD SUGAR AND HE ADVISED ME TO DISCONTINUE ITS USE UNTIL I COULD VERIFY IT WAS NOT MALFUNCTIONING. AFTER DISCHARGE FROM THE HOSPITAL, MY BLOOD SUGAR WAS BETWEEN 250 AND 400 FOR THE REMAINDER OF THE EVENING. I WOKE UP HOURLY THROUGHOUT THE NIGHT TO CHECK MY BLOOD SUGAR AND ADMINISTER INSULIN VIA NEEDLE AND SYRINGE. AFTER A LONG AND TIRING NIGHT, I WAS ABLE TO GET IT WITHIN NORMAL LIMITS. FURTHERMORE, MY (B)(6) SON HAS BEEN TRAUMATIZED BY THIS INCIDENT. HE NOW ASKS ME 10 TO 15 TIMES A DAY IF I'VE CHECKED MY BLOOD SUGAR; HE REQUIRES CONSTANT REASSURANCE THAT HE CAN RELY UPON ME. SINCE THE INCIDENT OF (B)(6) 2010, HE HAS REFUSED TO GET IN THE CAR IF I AM DRIVING AND HAS BEEN SEEING BOTH A PSYCHIATRIST AND PSYCHOLOGIST FOR ANXIETY THAT HAS BEEN EXACERBATED ENORMOUSLY BY THIS INCIDENT. AFTER RETURNING HOME FROM THE HOSPITAL, I CALLED YOUR 24 HOUR HELP LINE AND ASKED FOR ASSISTANCE. I WAS TOLD BY THE CLINICAL PERSON WORKING THE PHONES THAT NIGHT THAT THERE WOULD NOT BE AN EFFORT TO DO A FORENSIC EXAM OF MY PUMP. THIS CONCERNS ME GREATLY AS I BELIEVE THE FDA MUST BE MADE AWARE OF THIS INCIDENT AND ANY OTHERS LIKE IT. I HAD PRESUMED SMITHS-MEDICAL WOULD REPORT THIS PUMP MALFUNCTION AS PART OF A COMPREHENSIVE CLINICAL QUALITY PROGRAM. MOREOVER, I BELIEVED THAT I WOULD RECEIVE FURTHER CONTACT TO ASSIST YOUR COMPANY IN INVESTIGATING THIS PROBLEM FURTHER. UNFORTUNATELY, THIS HAS NOT BEEN THE CASE. I HAVE RECEIVED NO FURTHER COMMUNICATION FROM YOUR COMPANY WHATSOEVER, BESIDES RECEIVING TWO LETTERS TELLING ME THAT I HAD NOT RETURNED MY PUMP, WHEN IN FACT, I HAD INDEED DONE SO. NEEDLESS TO SAY I HAVE BEEN THUS FAR UNDERWHELMED BY SMITH-MEDICAL'S CUSTOMER SERVICE IN THIS INCIDENT. I AM RELYING ON YOU TO HELP CORRECT THIS SITUATION. PLEASE BE AWARE THAT I HAVE HAD MY ENDOCRINOLOGIST REVIEW THE PUMP "DELTEK COZMO INSULIN PUMP, (B)(6)", PROVIDED BY YOUR COMPANY. HE HAD THE DIABETES PUMP SPECIALIST (B)(6) MEDICAL CENTER EVALUATE THE DEFECTIVE PUMP. THE SPECIALIST FOUND THAT WHEN A BOLUS WAS PROGRAMMED, SIGNIFICANTLY MORE INSULIN WAS DELIVERED THAN PROGRAMMED. THERE IS NO DOUBT THAT YOUR DELTEK COZMO, (B)(6) DEFECTIVE PUMP IS THE PROXIMATE CAUSE OF MY CAR ACCIDENT. AS A HEALTHCARE PROFESSIONAL WHO DILIGENTLY MANAGES HER DIABETES, I AM GREATLY GRIEVED BY THIS INCIDENT. I HAD JUST CHECKED MY BLOOD SUGAR BEFORE LEAVING TO PICK UP MY CHILD. I TRUSTED SMITHS-MEDICAL TO MANUFACTURE A DEPENDABLE PRODUCT; I AM DEVASTATED TO HAVE SINCE BEEN PROVEN OTHERWISE. INDEED, I TRUSTED MY LIFE AND MY CHILD'S TO MY SMITHS-MEDICAL DELTEC COZMO PUMP. I AM NOW FACED WITH REPAIRING MY BRAND NEW (B)(6) WHICH SUSTAINED OVER (B)(6) IN DAMAGE AS A RESULT OF SMITHS-MEDICAL'S DEFECTIVE PUMP. I DO NOT BELIEVE THAT I AM RESPONSIBLE FOR THE DAMAGE TO MY VEHICLE; THERE IS NOTHING MORE I COULD HAVE DONE TO PREVENT THIS INCIDENT. IT IS UNCONSCIONABLE THAT I AND MY FAMILY SHOULD INCUR THIS TYPE OF TRAUMA AS A RESULT OF A DEFECTIVE PRODUCT AND HAVE TO PAY FOR THE DAMAGES TO OUR FAMILY CAR AS WELL. THE EXPENSE TO REPAIR OUR CAR SHOULD NOT BE INCURRED BY ME OR MY CAR INSURANCE, BUT BY SMITH-MEDICAL. SMITH-MEDICAL'S PUMP, (B)(6), MALFUNCTIONED AND CAUSED MY BLOOD SUGAR TO PLUMMET, RESULTING IN THE CAR ACCIDENT ON (B)(6) 2010. I AM VERY THANKFUL THAT MY SON AND I WERE NOT KILLED OR SEVERELY INJURED. I HAVE INCLUDED THE ESTIMATE FOR REPAIR OF MY VEHICLE AS WELL AS THE MEDICAL BILLS FOR THE EMERGENCY TREATMENT I RECEIVED AS A RESULT OF THAT ACCIDENT. FOR YOUR CONVENIENCE, I HAVE ALSO INCLUDED DOCUMENTATION FROM MY MEDICAL CHART FROM THE CLINICIAN THAT EXAMINED MY PUMP DETAILING HER FINDINGS. SEE SCANNED PAGES. DOSE OR AMOUNT: REGULAR INSULIN, ROUTE: INSULIN PUMP.