Description of Event or Problem · 1
THIS CASE WHICH INVOLVES AN ADVERSE EVENT, REPORTED BY A NON-HEALTHCARE PROFESSIONAL WHO CONTACTED THE COMPANY TO REPORT A PRODUCT COMPLAINT AND ADVERSE EVENT, CONCERNS A PATIENT OF UNKNOWN ORIGIN. THE PATIENT'S MEDICAL HISTORY INCLUDED HIGH BLOOD PRESSURE. CONCOMITANT MEDICATIONS INCLUDED DOXAZOSIN AND AN UNSPECIFIED SECOND MEDICATION FOR HIGH BLOOD PRESSURE. THE PATIENT RECEIVED 20 % SOLUBLE INSULIN/ 80 % ISOPHANE INSULIN (HUMULIN M2), 12 UNITS IN THE MORNING AND 16 UNITS AT NIGHT, VIA A HUMAPEN ERGO TEAL PEN BODY (LOT 40296) WITH A CLEAR CARTIDGE HOLDER ATTACHED FOR THE TREATMENT OF DIABETES BEGINNING ON AN UNSPECIFIED DATE. SIX WEEKS PRIOR TO THIS REPORT, WHILST RECEIVING THE THERAPY MENTIONED ABOVE, THE PATIENT EXPERIENCED HYPOGLYCAEMIA. THE PARAMEDICS WERE CALLED AND THE PATIENT WAS TREATED WITH GLUCAGON. IN 2003 THE PATIENT USED A NEW CARTRIDGE OF 20 % SOLUBLE INSULIN/ 80 % ISOPHANE INSULIN (LOT NUMBER FF2M58D EXP. 31-JUL-2004) AND THE PATIENT EXPERIENCED HIGH BLOOD SUGARS OF 30 AND LATER THE SAME DAY SUFFERED "HYPOS" AFTER OVER COMPENSATING FOR THE PREVIOUS LACK OF INSULIN. THE REPORTER STATED THAT THE CARTRIDGE BROKE WHEN INSERTING IT INTO THE PEN WITH THE DAMAGE OCCURRING AT THE TOP OF THE CARTRIDGE. THE REPORTER ALSO STATED THAT THIS HAD OCCURRED ON SEVERAL OCCASIONS WITH THREE OUT OF THE LAST TEN CARTRIDGES HAVING BROKEN. IT WAS ALSO NOTED THAT THE PATIENT HAD RECEIVED THREE HUMAPENS SINCE THE BEGINNING OF 2003. THE PATIENT HAD TWO HUMAPENS WHICH WERE REPORTED NOT TO BE DELIVERING INSULIN AND THERE WAS VARIABILITY OF THE DOSE KNOB. THE REPORTER IDENTIFIED THAT THE ENGAGEMENT TABS, DOSE KNOB AND FOOTPAD WERE ALL PRESENT ON ONE PEN. THE DEVICES WERE OPERATED BY THE PATIENT WHO HAD BEEN TRAINED AT A DIABETIC CLINIC. THE PATIENT USED BECTON DICKINSON NEEDLES BUT THE LENGTH AND GUAGE OF THE NEEDLES WAS UNKNOWN. THE PATIENT REUSED THE NEEDLES TWICE BEFORE CHANGING THEM. THE DEVICE WAS STORED INSIDE. THE REPORTER STATED THAT THE PATIENT PRIMED THE PEN AND INJECTED INTO THEIR LEG. THE RETURN OF TWO DEVICES IS ANTICIPATED. THE TWO HUMAPEN ERGO COMPLAINTS ARE ASSOCIATED WITH CID00191011 AND CID00191008. THE AT THE TIME OF REPORTING, THERAPY WITH 20 % SOLUBLE INSULIN/ 80 % ISOPHANE INSULIN WAS CONTINUING AND THE PATIENT WAS RECOVERING FROM THE EVENTS. THE INSULIN CARTRIDGE CONCERNED (LOT FF2M58D, EXP. 31-JUL-2004) IS BEING RETURNED FOR ANALYSIS. THE 20 % SOLUBLE INSULIN/ 80 % ISOPHANE INSULIN COMPLAINT IS ASSOCIATED WITH CID00191767. THESE EVENTS WERE UNASSESSED BY A HEALTHCARE PROFESSIONAL. UPDATE 22-JUL-2003: CID NUMBERS AND CAUSALITY STATEMENT ENTERED INTO NARRATIVE. CIOMS COMMENTS ALSO UPDATED. EXPECTED FOLLOW-UP DATE ADDED IN SUSPECT DEVICE PAGE. ASSOCIATED DEVICES WITH PATIENT EVENTS. UPDATE 23-JUL-2003: CID NUMBER FOR INSULIN CARTIDGE RECEIVED FROM QA ON 23-JUL-2003. CASE UPDATED ACCORDINGLY.