Description of Event or Problem · 1
THIS CASE, REPORTED BY A NON-HEALTHCARE PROFESSIONAL WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT, CONCERNS A PATIENT. THE PATIENT HAD NO MEDICAL HISTORY OF NOTE AND WAS NOT RECEIVING ANY CONCOMITANT MEDICATIONS. THE PATIENT RECEIVED 25% INSULIN LISPRO, 75% INSULIN LISPRO PROTIMNE (HUMALOG), 28 UNITS AND 18 UNITS A DAY, DELIVERED VIA A HUMAPEN ERGO BURGENDY/CLEAR PEN BODY (LOT 40268) WITH A CLEAR CARTRIDGE HOLDER ATTACHED, FOR THE TREATMENT OF DIABETES BEGINNING IN 2003. MONTHS LATER THREE TO FOUR MONTHS AFTER COMMENCING 25% INSULIN LISPRO, 75% INSULIN LISPRO PROTAMINE VIA A HUMAPEN, THE PATIENT EXPEREINCED HIGH BLOOD SUGARS OF 13-14 (NORMAL 4-8) AND LOW BLOOD SUGARS OF 3-4. IN ADDITION, THE PATIENT ALSO FELT DIZZY AND SUFFERED HEADACHES AND VOMITING AND WAS ADMITTED TO HOSPITAL OVERNIGHT. THE REPORTER BELIEVED THAT THERE WERE PROBLEMS WITH THE LEADSCREW OF THE PEN. THE PERSON OPERATING THE DEVICE WAS THE PATIENT. IT WAS UNKNOWN IF THE OPERATOR OF THE DEVICE WAS TRAINED. THE PATIENT USED 5 MM BECTON DICKINSON NEEDLES AND CHANGED THE NEEDLE AFTER EVERY INJECTION. THE PATIENT ALWAYS PRIMED THE PEN AND HELD THE NEEDLE IN THE SKIN FOR GREATER THAN FIVE SECONDS. THE PATIENT HAD USED THE DEVICE FOR FOUR MONTHS AND STORED IT INSIDE AT ROOM TEMPERATURE. AT THE TIME OF REPORTING THE PATIENT WAS RECOVERING AND THERAPY WITH 25% INSULIN LISPRO, 75% INSULIN LISPRO PROTAMINE CONTINUED, THIS HUMAPEN ERGO COMPLAINT IS ASSOCIATED WITH CID00212459. THESE EVENTS ARE UNASSESSED BY A HEALTHCARE PROFESSIONAL. THE DEVICE WAS RETURNED TO THE COMPANY. THE DEVICE IS BEING SENT TO THE MANUFACTURER FOR EVALUATION AND CONCLUSION IS PENDING. UPDATE 25-NOV-2003: INITIAL GPCMS REPORT RECEIVED ON 21-NOV-003, PEN TYPE CHANGED TO BURGENDY CLEAR PEN BODY WITH A CLEAR CARTRIDGE HOLDER ATTACHED. DEVICE AND NARRATIVE PAGES UPDATED ACCORDINGLY. UPDATE 01-DEC-2003: PATIENT'S HEALTHCARE PROFESSIONAL DETAILS RECEIVED 27-NOV-2003. CASE UPDATED ACCORDINGLY.