Description of Event or Problem · 1
THE DEVICE CASE, REPORTED BY A NON HEALTH CARE PROFESSIONAL WHO CONTRACTED THE COMPANY WITH A PRODUCT COMPLAINT, CONCERNS PT. THE PT WAS NOT RECEIVING ANY CONCOMITANT MEDICATION. THE PT HAS BEEN ADMINISTERING THEIR OWN INJECTING SINCE THE AGE OF FOUR. THE PT HAS BEEN USING PEN INJECTION DEVICES (HUMAPEN ERGO-CLEAR CARTRIDGE HOLDER) TO DELIVER 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN SOLUTION (HUMULIN M2). THE REPORTER STATES THAT THE PT THOUGHT THAT THEY HAD BROKEN THE PEN AND WAS FRIGHTENED TO TELL ANYONE. THE PT SUFFERED HIGH BLOOD SUGARS AND VOMITING AND IN 2002 WAS ADMITTED TO HOSPITAL WITH KETOACIDOSIS. THE PT WAS ADMITTED TO THE HOSPITAL. WHILE IN HOSPITAL THE PT WAS PUT ON AN INSULIN DRIP, SALINE DRIP, AND WAS MONITORED. THE PT WAS DISCHARGED FROM HOSPITAL IN MAY 2002. THE REPORTER STATES THAT THE PT HAS HAD THE SAME PROBLEM WITH TWO PREVIOUS PENS (CLEAR CARTRIDGE HOLDERS) AND THAT THEY ONLY LASTED 6-8 WEEKS. IN EACH CASE THE PLUNGER WOULD NOT MOVE DOWN. THE PT CAN DIAL A DOSE BUT CAN NOT DEPRESS THE DOSE KNOB. IT COMPLETELY JAMS AND THE PT DOES NOT GET A FULL INSULIN DOSE. THE NEEDLES THAT THE PT USES ARE BD MICROFINE 31G 8MM AND THEY ARE CHANGED WITH EVERY INJECTION. ONE HUMAPEN ERGO-BURGENDY CLEAR CARTRIDGE HOLDER RETURNED. INITIAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE GENERAL CONDITION OF THE PEN WAS GOOD. THE INJECTION BUTTON WAS DETACHED AND NOT RETURNED. PHARMACEUTICAL DELIVERY SYSTEMS PROVIDED DETAILED ANALYSIS RESULTS ON JULY-2002: ONE COMPLAINT DEVICE EQUIPPED WITH A CLEAR CARTRIDGE HOLDER, WAS RETURNED FOR INVESTIGATION. THE INJECTOR BUTTON WAS DETACHED THUS IT WAS NOT POSSIBLE TO CONDUCT DOSE ACCURACY GLIDE FORCE TESTING AND THE PT COMPLAINT THAT THE DEVICE COMPLETELY JAMS COULD NOT BE CONFIRMED. THE CAUSE FOR THE DETACHED INJECTION BUTTON HAS NOT BEEN IDENTIFIED. TREND ANALYSIS OF DETACHED INJECTION BUTTONS INDICATES NO CLEAR TREND AND THEREFORE MANUFACTURING DEFECTS ARE NOT CONSIDERED THE ROOT CAUSE. AT THE TIME OF REPORTING THE EVENT OF KETOACIDOSIS HAD ABATED AND THE PT OUTCOME WAS UNKNONW. IT IS UNKNOWN WHETHER THE EVENTS OF HIGH BLOOD SUGARS AND VOMITING WERE CONTINUING. 20% SOLUBLE INSULIN/80% ISOPHANE INSULIN SOLUTION WAS CONTINUING. THE EVENTS WERE NOT ASSESSED BY A HEALTH CARE PROFESSIONAL. UPDATE 04-JUL-2002: MINOR CORRECTIONS MADE TO THE NARRATIVE AND EXPECTEDNESS REMOVED FROM NON-SERIOUS EVENTS. CASE UPDATED. UPDATE 23-JUL-2002: PHARMACEUTICAL DELIVERY SYSTEMS ENTERED RESULT/CONCLUSIONS ON THE SUSPECT DEVICE PAGE, UPDATED THE NARRATIVE AND THE CIOMS-II FIELD. UPDATE 24-JUL-2002: INITIAL GPCMS (RECEIVED 18-JUL-2002) AND FINAL REPORT (RECEIVED 23-JUL-2002) RECEIVED FROM QA CASE UPDATED ACCORDINGLY.