Description of Event or Problem · 1
THIS DEVICE CASE, REPORTED BY A DIABETES NURSE EDUCATOR (DNE) VIA A SALES REPRESENTATIVE WITH ADDITIONAL INFORMATION FROM A SECOND DNE, CONCERNS A PT WHO EXPERIENCED DIABETIC KETOACIDOSIS. THE PT WAS RECEIVING HUMAN INSULIN ISOPHANE SUSPENSION (HUMULIN N) VIA A PEN INJECTOR DEVICE (HUMAPEN ERGO, TEAL-CLEAR) AND LISPRO INSULIN (HUMALOG) VIA A PEN INJECTOR DEVICE (HUMAPEN ERGO, BURGUNDY-CLEAR) FOR TREATMENT OF TYPE I DIABETES. THE PT OPERATED THE DEVICE AND WAS A TRAINED USER (THE SECOND REPORTING DNE TRAINED THE PATIENT). THE DEVICE WAS IN USE SINCE THE SPRING 2001 (LESS THAN SIX MONTHS). THE PATIENT IS A NEWLY DIAGNOSED TYPE I DIABETIC. PT WAS DIAGNOSED IN THE SPRING OF 2001. PT WAS REFERRED TO A HOSPITAL DIABETES CARE CENTRE WHERE PT RECEIVED TWO HUMAPENS ALONG WITH TRAINING. PT WAS THEN REFERRED TO AN ENDOCRINOLOGIST WHO WAS FOLLOWING THEIR TREATMENT. PT HAD PHONE CONTACT WITH THE ENDOCRINOLOGIST FOR INSULIN DOSE ADJUSTMENTS. IT IS UNKNOWN IF THE PT WAS TAKING ANY CONCOMITANT MEDICATIONS. IN 2001 DURING TREATMENT WITH HUMULIN N AT BEDTIME VIA THE HUMAPEN (LOT# 40005 / MODEL# MS8929) AND HUMALOG 8 UNITS WITH MEALS VIA THE HUMAPEN (LOT# 40027 / MODEL# MS8930) THE PT FELT ILL, WAS DEHYDRATED, HAD ELEVATED BLOOD SUGARS (VALUE UNKNOWN) AND THOUGHT THEY HAD THE FLU. PT LEFT A VOICE MAIL MESSAGE FOR THE DNE LATE ONE EVENING REGARDING THEIR SYMPTOMS. LATER THAT EVENING PT EXPERIENCED VIOLENT VOMITING AND AT 0400 HOURS WENT TO THE HOSPITAL EMERGENCY AND WAS ADMITTED WITH DIABETIC KETOACIDOSIS. PT REMAINED IN THE INTENSIVE CARE UNIT FOR FOUR DAYS. THE DNE DID NOT HAVE ANY DETAILS REGARDING THEIR ADMITTING LAB RESULTS. DURING THE PATIENT'S HOSPITALIZATION PT RECEIVED THEIR INSULIN VIA A SYRINGE. ACCORDING TO THE PATIENT'S SPOUSE THE PT HAD BEEN HAVING PROBLEMS WITH THEIR HUMAPENS AND SPOUSE RETURNED THEM TO THEIR PHARMACY AND RECEIVED NEW ONES. ON SEVERAL OTHER OCCASIONS THE PATIENT'S SPOUSE RETURNED THE HUMAPENS TO THE PHARMACY AND RECEIVED NEW ONES. THE DNE DID NOT KNOW WHICH PHARMACY THE PATIENT RECEIVED THE HUMAPENS FROM. SPOUSE DESCRIBED THE PROBLEM AS THE BLACK SCREW NOT PUSHING FORWARD. SPOUSE ALSO NOTED THAT THEY REALIZED THERE WAS A PROBLEM WHEN THE INSULIN CARTRIDGES WERE NOT BEING USED UP. THE PT WAS RELEASED FROM HOSPITAL AFTER FOUR DAYS AND THE FOLLOWING DAY WENT BACK TO THE DNE'S DIABETES CARE CENTRE. AT THIS TIME THE PT WAS CONTINUING TO USE THE HUMULIN N AND HUMALOG VIA THE HUMAPENS. WHEN PT SAW THE DNE THEIR BLOOD SUGAR WAS STILL ELEVATED AND PT WAS IN CONTACT WITH THEIR ENDOCRINOLOGIST TO HAVE THEIR INSULIN DOSE ADJUSTED. THE DNE INSPECTED THE TWO HUMAPENS AND NOTED THAT THE HUMAPEN USED TO DELIVER HUMULIN N (LOT# 40005 / MODEL# MS8929) WAS FUNCTIONING PROPERLY. HOWEVER, THE HUMAPEN USED TO DELIVER HUMALOG (LOT# 40027 / MODEL MS8930) WAS NOT FUNCTIONING CORRECTLY. SHE NOTED THAT THE BLACK SCREW MOVED FORWARD INTERMITTENTLY (IT WORKED SOMETIMES AND NOT OTHERS). THE PT DECIDED TO DISCONTINUE USING THE HUMAPENS AND IS NOW USING SYRINGES. THE DEVICES WERE RETURNED TO THE COMPANY FOR ANALYSIS. AN INITIAL INSPECTION OF THE RETURNED DEVICES REVEALED THAT THE HUMAPENS APPEAR TO BE FUNCITONING NORMALLY AND ALL COMPONENTS WERE INTACT. THE REPORTER DNE STATED THAT THE EVENT IS POSSIBLY RELATED TO THE HUMAPEN. THIS REPORT IS CROSS-REFERENCED TO THE GLOBAL PRODUCT COMPLAINTS MANAGEMENT SYSTEM (GPCMS) DATABASE FOR DEVICE LOT NUMBER 40005.