Description of Event or Problem · 1
DISTURBANCE OF CONSCIOUSNESS, FATIGUE, WEAK, PALPITATION, NAUSEA, VOMITING, DIARRHEA AND SWEAT [ALTERED STATE OF CONSCIOUSNESS] HYPOKALEMIA [HYPOKALAEMIA], DIARRHEA [DIARRHOEA], SWEAT [HYPERHIDROSIS], HYPOGLYCEMIA [HYPOGLYCAEMIA], MYOCARDIAL ISCHEMIA [MYOCARDIAL ISCHAEMIA], VENTRICULAR PREMATURE BEATS [EXTRASYSTOLES]. CASE DESCRIPTION: THIS SPONTANEOUS CASE REPORTED BY AN ENDOCRINOLOGIST, RECEIVED FROM ANOTHER COUNTRY REPORTED AS "DISTURBANCE OF CONSCIOUSNESS, FATIGUE, WEAK, PALPITATION, NAUSEA, VOMITING, DIARRHOEA AND SWEAT", CONCERNS A MALE PT TREATED WITH NOVOMIX 30 FLEXPEN (DUAL-ACTING INSULIN ASPART) FOR THREE DAYS IN 2007 AND NOVOFINE 30G NEEDLE FOR INSULIN-REQUIRING TYPE II DIABETES MELLITUS. ON TWO DAYS PRIOR TO TREATMENT DATE, THE PT WAS TREATED WITH NOT-CODED MEDICATION: GUANXIN DANSHEN DRIPPING PILL. MEDICAL HISTORY OSTEOPOROSIS AND OLD MULTIPLE FRACTURE. ON THE SAME DAY, THE PT WAS ADMITTED TO HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVEL FOR ONE YEAR. ON FOUR DAYS LATER, 2 HRS AND 20 MINS. AFTER LAST INJECTION, THE PT EXPERIENCED DISTURBANCE OF CONSCIOUSNESS, FATIGUE, WEAKNESS, PALPITATION, NAUSEA, VOMITING, DIARRHEA AND SWEAT. THE PT HAD LOST HIS APPETITE THAT DAY AND DID NOT DRINK AND EAT AS MUCH AS USUAL AFTER INJECTION. THE BLOOD GLUCOSE LEVEL WAS MEASURED IMMEDIATELY, IT WAS 0.8 MMOL/L, ECG SHOWED FREQUENT POLYMORPHIC MULTIFORM VENTRICULAR PREMATURE BEATS ANY MYOCARDIAL ISCHEMIA. TEST RESULTS: BLOOD POTASSIUM (K+): 1.81 MMO/L, BLOOD CREATINE (CREA): 124.7MMOL/L, CREATINE KINASE (CK): 137 IU/L, BLOOD CREATINE PHOSPHOKINASE (CKMB): 50.2 IU/L. THE PT WAS TREATED WITH: 50% GLUCOSE SOLUTION (100 ML BY INTRAVENOUS DRIPPING), 10% GLUCOSE SOLUTION 500 ML. BY ORAL ADMINISTRATION, GLUCOSE INSULIN POTASSIUM (GIK) SOLUTION BY INTRAVENOUS DRIPPING, 10% KCL SOLUTION BY ORAL,, NITROGLYCERIN, SUBLINGUAL ADMINISTRATION. AFTER THE TREATMENT THE BLOOD TESTS WERE DONE AGAIN: BLOOD GLUCOSE: 13,5 MMOL/L, BLOOD POTASSIUM (K+): 3,72 MMOL/L, AND THE NEW ECG TEST WAS NORMAL. THE SUSPECTED PRODUCT WAS SWITCHED TO NOVOLIN R. THE BLOOD GLUCOSE WAS CONTROLLED WELL AND THE PT RECOVERED COMPLETELY. ON THE FOLLOWING MONTH, THE PT WAS DISCHARGED FROM HOSPITAL. REPORTER'S CAUSALITY: PROBABLE, NOVO NORDISK CAUSALITY: REPORTABLE. ANALYSIS RESULTS RECEIVED FROM CCC: PRODUCT: NOVOMIX 30 FLEXPEN LOT NO: TP50075, DRUG CONCLUSION: CARTRIDGE/PREPARATION: THE RETURN PRODUCT WAS EXAMINED VISUALLY. FURTHERMORE, THE PARAMETERS IDENTITY, ASSAY, DEGRADATION, AND INSULIN ASPART RELATED IMPURITIES WERE EXAMINED. THE PRODUCT WAS FOUND TO BE NORMAL. THE RESULTS WERE FOUND TO COMPLY WITH SPECIFICATIONS. DEVICE CONCLUSION: PEN PARTS/MECHANISM: VISUAL AND FUNCTIONAL EXAMINATIONS WERE PERFORMED. THE DOSE ACCURACY WAS MEASURED BY WEIGHING. THE RESULT WAS WITHIN ACCEPTABLE LIMITS. DURING TESTING OF THE DEVICE, IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. A GAP BELOW OR EQUAL TO 12 IU IS OBSERVED BETWEEN PISTON AND PISTON ROD. PRODUCT: NOVOFINE G30,8MM LOT NO: NA, NEEDLE CONCLUSION: DURING TESTING OF THE ACTUAL NEEDLE, IT HAS NOT BEEN POSSIBLE TO DETECT ANY IRREGULARITIES. CASE CONCLUSION: PRODUCT INFORMATION: NOTHING ABNORMAL WAS FOUND WITH THE DEVICE MECHANISM AND THE PREPARATION. THE OBSERVED PROBLEM WITH THE GAP IS DUE TO INCORRECT HANDLING DURING USE. PRODUCT INFORMATION: NOT ABNORMAL WAS FOUND WITH THE DEVICE. COMMENT: COMPANY COMMENT: THE HYPOKALEMIA COULD BE SECONDARY TO THE GASTROINTESTINAL SYMPTOMS. HYPOKALEMIA IS KNOWN TO BE ABLE TO CAUSE ARRHYTHMIAS. THE REPORTED SYMPTOMS DISTURBANCE OF CONSCIOUSNESS AND SWEAT CAN BE ATTRIBUTED TO THE HYPOGLYCEMIC EVENT. THE DIARRHOEA CAN BE CAUSED BY NUMEROUS FACTORS INCLUDING BOTH THE HYPOGLYCEMIA, THE HYPOKALEMIA AND THE CONCOMITANT MEDICATION CALCITONIN. THE REPORTER COMMENTS ON ELDERLY PTS WITH KIDNEY DYSFUNCTION, HOWEVER, IT HAS NOT BEEN REPORTED IF THIS PT HAD A HISTORY OF KIDNEY DYSFUNCTION. COMMENT: REPORTER'S COMMENTS: THE INSULIN WHICH CONTAINS LONG ACTING COMPONENT SHOULD BE USED DISCREETLY IN ELDER PTS WITH KIDNEY DYSFUNCTION.