Description of Event or Problem · 1
THIS DEVICE CASE, REPORTED BY A NON-HEALTHCARE PROFESSIONAL WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, WITH FOLLOW-UP INFORMATION FROM THE INITIAL REPORTER, CONCERNS THE PATIENT. THE PATIENT'S MEDICAL HISTORY INCLUDED HAVING DIABETES SINCE 5 YEARS OLD. PATIENT HAS ALWAYS HAD GOOD CONTROL OF PATIENT DIABETES. CONCOMITANT MEDICATION INCLUDED INSULIN LISPRO (HUMALOG) 6-10 UNITS THREE TIMES A DAY, STARTED SEVERAL YEARS AGO. THE PATIENT RECEIVED ISOPHANE INSULIN (HUMULIN I), 34 UNITS AT NIGHT TIME, DELIVERED VIA A PEN INJECTION DEVICE (HUMAPEN ERGO - CLEAR CARTRIDGE HOLDER) FOR THE TREATMENT OF TYPE I DIABETES, BEGINNING SEVERAL YEARS AGO. IN APR-2003, THE PATIENT EXPERIENCED GENERAL ILLNESS, LETHARGY, EXTREME VOMITING, SEVERE STOMACH PAINS AND DISTRESSING WEIGHT LOSS (THE PATIENT LOST 1.5 STONES IN A WEEK). THE PATIENT ALSO EXPERIENCED EXTREMELY HIGH BLOOD SUGARS OF 36 MMOL/LITRE AND KETONES IN THE URINE, RESULTING IN KETOACIDOSIS. THE REPORTER STATED THAT THE PATIENT'S HUMAPEN HAD ALWAYS FELT STIFF. WHEN GIVING THE NIGHT TIME INJECTION OF ISOPHANE INSULIN THE REPORTER STATED THE PATIENT HAD NOTICED LIQUID ON THE SKIN FOR A COUPLE OF DAYS IN A ROW, BUT DID NOT SEE WHERE IT HAD COME FROM. WHEN PATIENT CHANGED THE CARTRIDGE PATIENT NOTICED LIQUID IN THE CARTRIDGE BEHIND THE PLUNGER AS IF THE INSULIN WAS LEAKING BACK INTO THIS SPACE INSTEAD OF EXITING VIA THE NEEDLE. WHEN PATIENT INSERTED A NEW CARTRIDGE AND PERFORMED AN INJECTION THE INSULIN CAME OUT OF THE SIDE OF THE CARTRIDGE HOLDER/PEN. THE PATIENT DID NOT EXAMINE THE CARTRIDGE FOR CRACKS, BUT THE REPORTER STATED THE PATIENT FELT SURE THE PROBLEM WAS WITH THE PEN RATHER THAN THE CARTRIDGES SINCE IT OCCURRED WITH TWO CARTRIDGES. THE PATIENT DOES NOT PRIME THE PEN SINCE PATIENT FEELS THAT IT IS NOT NECESSARY IF THE PEN IS OF GOOD QUALITY AND HAS NEVER HAD A DEVICE FAIL TO DELIVER INSULIN BEFORE. THE REPORTER STATED THE PATIENT DOES NOT WANT TO RETURN THE PEN AS PATIENT DOES NOT TRUST THE COMPANY, HOWEVER PATIENT IS RETURNING THE DEVICE TO THE DIABETES NURSE FOR HER TO HAVE ANOTHER LOOK AT. PHARMACETICAL DELIVERY SYSTEMS PROVIDED INITIAL COMMENTS IN MAY-2003: WHEN THE MANUFACTURER (PDS) RECEIVES THE COMPLAINT DEVICE, AN INVESTIGATION WILL BE PERFORMED AND THE RESULTS REPORTED AS REQUIRED. NO MATERIAL WAS RETURNED TO THE MANUFACTURER FOR EXAMINATION, THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE DEFECT. THE PATIENT INCREASED THE DAY TIME INSULIN LISPRO DOSAGES TO BRING THE BLOOD SUGARS DOWN AND RECOVERED IN APR-2003, APPROXIMATELY ONE WEEK AFTER THE EVENTS STARTED. THE PATIENT IS GOING TO SWITCH TO LANCTUS INSULIN. THE PEN INJECTION DEVICE IS NOT AVAILABLE FOR FURTHER ANALYSIS. FURTHER INFORMATION WILL BE REQUESTED. AT INITIAL REPORT ON THE APR-2003, THIS CASE WAS NON SERIOUS. THIS CASE BECAME SERIOUS WITH FOLLOW UP INFORMATION RECEIVED ON THE MAY-2003. UPDATE MAY-2003: PHARMACEUTICAL DELIVERY SYSTEMS ENTERED INITIAL COMMENTS ON THE SUSPECT DEVICE PAGE AND UPDATED THE NARRATIVE. AT INITIAL REPORT IN APR-2003, THIS CASE WAS NON SERIOUS, THIS CASE BECAME SERIOUS WITH FOLLOW UP INFORMATION RECEIVED IN MAY-2003. FINAL GPCMS REPORT RECEIVED FROM QA ON THE MAY-2003. FINAL COMMENTS ADDED AND CASE UPDATED ACCORDINGLY. CIOMS COMMENTS ALSO UPDATED TO INCLUDED DETAILS OF DEVICE FAULT.