Description of Event or Problem · 1
THE PATIENT'S MEDICAL HISTORY INCLUDED "BARRET'S OESOPHAGUS" AND SUFFERING FROM MIGRAINES. THE PT HAS BEEN DIABETIC FOR 10 YEARS AND STARTED ON AN INSULIN MIX WHICH DID NOT WORK AND WAS MOVED ONTO SOLUBLE AND ISOPHANE INSULIN 7-8 YEARS PRIOR TO THIS REPORT. CONCOMITANT MEDICATION INCLUDED OMEPRAZOLE STARTED GREATER THAN 10 YEARS AGO AND PIZOTIFEN. THE PT RECEIVED SOLUBLE INSULIN (HUMULIN S) 12 UNITS IN THE MORNING, 6 UNITS AT LUNCH AND 20 UNITS IN THE EVENING, AND ISOPHANE INSULIN (HUMULIN I), 38 UNITS IN THE EVENING, DELIVERED VIA A HUMAPEN ERGO BURGENDY/OPAQUE PEN BODY (LOT UNKNOWN) WITH AN OPAQUE CARTRIDGE HOLDER ATTACHED FOR THE TREATMENT OF DIABETES, BEGINNING IN 1996. FOR THE LAST 18 MONTHS TO TWO YEARS THE PT HAS BEEN EXPERIENCING EPISODES OF LOW AND HIGH BLOOD SUGARS. DURING CHRISTMAS TWO YEARS PRIOR TO THIS REPORT (DEC-2001), THE PT EXPERIENCED A SERIOUS HYPOGLYCAEMIC EPISODE AT WORK WHICH REQUIRED PARAMEDICS ATTENTION. THE PT WAS GIVEN GLUCAGON. SINCE THEN THE PT HAS BEEN MONITORING THEIR BLOOD SUGARS THREE-FOUR TIMES A DAY. THE PT EXPERIENCES HIGH BLOOD SUGARS OF 14-15 USUALLY IN THE MORNING AND ALSO SUFFERS LOW BLOOD SUGARS OF 3.1 USUALLY WITHOUT WARNING SYMPTOMS. THE PATIENT'S NORMAL BLOOD SUGAR LEVELS ARE BETWEEN SEVEN AND NINE. THE PT ALSO BROKE THEIR LEG TWO YEARS AGO AND FEELS THAT THEIR INSULIN CONTROL HAS NEVER BEEN THE SAME SINCE. THE REPORTER STATED THAT THE PATIENT'S CLINIC MAY BE CHANGING THEIR INSULIN AS PT HAS STRUGGLED WITH THEIR BLOOD SUGAR CONTROL FOR ABOUT TWO YEARS. THE PT WORKS SHIFTS WHICH PT KNOWS DOES NOT HELP. THE REPORTER STATED THAT THE PATIENT'S HUMAPEN IS DIALING FINE AND THAT THE LEADSCREW APPEARED TO BE WORKING BUT THERE WAS NO INSULIN FLOW. THE PT HAS THROWN AWAY THE FAULTY PEN. THE OPERATOR OF THE DEVICE IS THE PATIENT. IT IS UNKNOWN IF THE OPERATOR IS A TRAINED USER. THE PT USED 30 GAUGE, 8MM NOVO NEEDLES AND CHANGES THEM WITH EVERY INJECTION. THE PT ALWAYS PRIMES THE PEN AND INJECTS INTO THEIR ABDOMEN OR THIGH HOLDING THE NEEDLE IN THE SKIN FOR FIVE SECONDS. THE PT HAS BEEN USING THE DEVICE TWO YEARS AND IT IS STORED INSIDE AT ROOM TEMPERATURE. AT THE TIME OF REPORTING THE PT HAD NOT RECOVERED AND THERAPY WITH SOLUBLE AND ISOPHANE INSULIN CONTINUES. THESE EVENTS ARE UNASSESSED BY A HEALTH CARE PROFESSIONAL. THE PEN IS NOT BEING RETURNED TO THE MANUFACTURER AS IT HAS BEEN DISCARDED. THE COMPLAINT DEVICE COULD NOT BE TESTED SINCE NO MATERIAL WAS RETURNED; THEREFORE NO MALFUNCTION COULD BE IDENTIFIED. DEFECTS THAT DO NOT IMPACT PERFORMANCE SPECIFICATIONS ON THIS PEN: NONE.STORAGE AND USAGE: BASED ON THE CUSTOMER COMPLAINT DESCRIPTION AND PRODUCT USE QUESTIONS, THERE IS NO EVIDENCE OF IMPROPER USE OR STORAGE.