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Diabetic ketoacidosis [diabetic ketoacidosis], hyperglycemia [hyperglycaemia].The test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out [device failure] did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin [wrong technique in product usage process].Case description: this serious spontaneous regulatory authority case received via "(b)(6)" from (b)(6) was reported by a consumer as "diabetic ketoacidosis" with an unspecified onset date, "hyperglycemia " with an unspecified onset date, "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" with an unspecified onset date, "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" with an unspecified onset date, and concerned a female patient (age between 10-18 years) who was treated with novopen 4 (insulin delivery device) from unknown start date due to "device therapy", actrapid penfill (insulin human) from unknown start date and ongoing for unknown indication" and unknown dose and frequency, insulatard penfill (insulin human) from unknown start date and ongoing for unknown indication and unknown dose and frequency.Patient's height, weight and body mass index: not reported.Medical history was not provided.It was reported that the patient had diabetic ketoacidosis, a few days after the patient started using penfill and novopen 4.It was reported that when the test was performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out, leading to problems in the application of the medication causing hyperglycemia.The patient was recovered and then the device was changed and the patient was retrained in the use of penfill and novopen 4.Also, it was reported that the patient did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin.Action taken to novopen 4 was not reported.Action taken to actrapid penfill was not reported.Action taken to insulatard penfill was not reported.The outcome for the event "diabetic ketoacidosis" was recovered.The outcome for the event "hyperglycemia " was recovered.The outcome for the event "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" was not reported.The outcome for the event "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" was not reported.This case is linked to (b)(4) (same reporter).Company comment: in this case the reported events are listed.More details are needed for the proper medical evaluation.Reporter comment: the (b)(6)classified the events as related to novopen 4, not to the insulins (actrapid and insulatard).
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Event verbatim [preferred term] (related symptoms if any separated by commas) urine with vestiges of leucocytes [urinary tract infection] diabetic ketoacidosis [diabetic ketoacidosis] hyperglycaemia [hyperglycaemia] the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out [device failure] did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin [wrong technique in product usage process] case description: this serious spontaneous regulatory authority case received via "ministry of health (cecmed)" from cuba was initially reported by a consumer and confirmed by health care professional as "urine with vestiges of leucocytes" beginning on (b)(6)2017 , "diabetic ketoacidosis" beginning on (b)(6)2017 , "hyperglycaemia" with an unspecified onset date, "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" beginning on (b)(6)2017, "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" with an unspecified onset date, and concerned a 18 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to diabetes mellitus, novopen 4 (insulin delivery device) from unknown start date due to "diabetes mellitus", actrapid penfill (insulin human) from (b)(6)2017for diabetes mellitus (regimen #1 dose and frequency 54 iu, qd; regimen #2 dose and frequency 14 u (at a rate of 0.2 uxkgxh); regiment #3 unknown dose and frequency) and insulatard penfill (insulin human) from (b)(6)2017for diabetes mellitus (regimen #1 dose and frequency 14 u, qd; regimen #2 unknown dose and frequency).The moh of cuba, reported to nn that 6 female patients between 10 - 18 years, presented diabetic ketoacidosis, a few days after the patients started using penfill.This case concerns one of the 6 patients.Patient's weight: 55 kg patient's height and body mass index were not reported.Medical history included diabetes mellitus (type and duration not reported).Treatment included - azithromycin(azithromycin), oseltamivir(oseltamivir), insulin(insulin; not specified) from (b)(6)2017, the patient presented epigastralgia of high intensity that radiated back, vomiting 7 times and fever not thermometrically verified, preceded by chills and tachycardia.The patient presented painful abdomen to deep palpation in the epigastrium.It was reported that the patient had diabetic ketoacidosis.On (b)(6)2017, at the hospital, the patient had a blood test performed with results of glucose tests: 18.3 mmol / l, urine with vestiges of leucocytes, complete blood count with results hto10 mol / l (not specified), leucocytes 10.6x109 / l, sec (not specified) 0.81 and lymphocyte 0.19 (unit not specified) which was interpreted as light leukocytosis with neutrophilia.On the same day , pco2 was 19.4 mmhg, po2 was 19.4 mmhg, ph was 7.16 (unit not applicable).The patient was hydrated with infusion pump 3l of ssf (not specified) 0.9% and 14 units of insulin actrapid at a rate of 0.2 uxkgxh.After hydration, glycemia was repeated with values of 15.5 mmol / l.The same day patient was sent to the hospital and a gasometry (non-codeable) was repeated, chest x-ray was performed, which reported a diffuse radio opacity on the left base and patient was admitted to intensive therapy reported as severe.A dietetic transgression was suspected because the mother said the patient ate croquettes.On (b)(6)2017, the patient began treatment with azithromycin 500 mg 1 tab / daily and oseltamivir 75 mg 1 cap each 12hours and insulin (not specified) according to glycemia levels.The patient compensated for the acidosis.On unspecified date, the patient recovered from hyperglycaemia and then the device was changed and the patient was retrained in the use of penfill and novopen 4.On (b)(6)2017, the patient returned to therapy after repeating the prescription and showed improvement but showed dehydration and fever.On (b)(6)2017, the patient's blood glucose values were 16.1 mmol/l at 12:00pm, 15.2 mmol/l at 4:00 pm, 10.1 mmol/l at 08:00pm.On (b)(6)2017, the patient's blood glucose values were 5.0 mmol/l at 12:00 am, 3.0 mmol/l at 04:00 am and 15.1 mmol/l at 08:00 am.It was reported that patient administered the medication by herself and kept it in refrigeration.The patient complied with the air ejection mechanism before administration, counted 6 seconds before removing the needle but the glucose was not always determined before administering the medication.Action taken to novopen 4 was not reported.Action taken to novopen 4 was not reported.Action taken to insulatard penfill was reported as drug discontinued temporarily.Action taken to actrapid penfill was reported as drug discontinued temporarily.The outcome for the event "urine with vestiges of leucocytes" was not recovered.The outcome for the event "diabetic ketoacidosis" was not recovered.The outcome for the event "hyperglycaemia" was recovered.The outcome for the event "the test is performed with the piston rod in the position indicated by the manufacturer, it did not trigger when the dose button was activated and therefore the insulin did not flow out" was not reported.The outcome for the event "did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin" was not reported.This case is linked to 584659, 584697, 584835, 584888, 584893 (same reporter).No further information available.Investigation result: insulatard penfill 100 iu/ml - batch fs61b38 the product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.Actrapid penfill 100 iu/ml - batch fs61b39 the product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.Since last submission, the case has been updated with the following: -seriousness criteria for diabetic ketoacidosis, device failure, hyperglycaemia updated as hospitalisation -event of "urine with vestiges of leucocytes" added.-patient codes updated -onset date and outcome for the event of diabetic ketoacidosis updated -age and weight of the patient was updated -medical history of the patient updated with diabetes mellitus -indication of insulatard penfill and actrapid penfill updated as diabetes mellitus -action taken to insulatard penfill and actrapid penfill updated as "drug discontinued temporarily" -start date, stop date and dosing regimen of insulatard penfill and actrapid penfill updated -treatment medications updated -laboratory data updated -medical confirmation updated -batch number of novopen 4 added (fvg9827 -1 and fvg9876-1) -reporter's comment updated -investigation result updated for insulatard penfill and actrapid penfill.-manufacturer's comment updated.-narrative updated accordingly reporter comment: all the patient's generally re-use the needles for the application of the medication.The functioning tests were performed with new needles and with 1 or 2 previous uses.In the case of administration of the medication for each patient, the needle was used up to 3 times each.In the practical demonstration of the devices in the room, individually with each patient, it was possible to witness the outflow of insulin before the administration of the drug and when the action was repeated without disassembling the needle and putting the supposed dose to be injected, there was no flow, evidencing that the spring did not exert any pressure on the penfil, although the clicks indicator returned to zero.All the patients reported that they liked the administration of this insulin because it does not burn and this may be the reason why they did not realize they did not receive the medication.In the individual interviews, only one girl said that she did not withdraw the needle at the end of the administration of the nph insulin when she used a new one in the first administration in the morning because she would use it in the remaining two applications of the day, but she always performed the disinfection.At the time it was recommended to all patients that they should always remove the needle using the established technique.No patient and family member reported that they had to make a different force to inject, making it easy to operate the dose button.All the patients used insulin suspension and stated that they always performed the re-suspension because they know it was the same type of insulin.The patient's as well as the family members had been trained by the pharmacist who carried out the dispensing of pen in the hospital pharmacy, who indeed was trained by the provincial pharmacoepidemiologist, who was present at the training carried out by the firm.In this regard we inform you that during the monitoring of patients until discharge, were visited daily in the different services to verify their evolution and it was possible to verify with each of them the status of each device in a personal way and the mastery of the techniques of use, in a practical way.This exchange served as a new training because at the time of delivery of the device in the hospital pharmacy, both the patient and the family received training for the use of it by the licensees in charge.The device was never delivered to family members if patients were not present.It was valid to point out that several of the patients had received a first training months before, during their participation in the provincial camp for diabetic children which takes place annually in the summer vacation period.From this first training there was much expectation with the beginning of the use of the new method of administration of insulins.None of the patient's reported changes in diet.The entire patient's inserted needles into the pen at a 180 degree angle and they all showed knowledge related to the needle insertion angle.It was always clarified in the trainings that although the manufacturer recommends storage at room temperature, in cuba it is never less than 30 degrees therefore, we recommended placing the penile near the water pommel that each one carries to the school, or keeping it in cool place at home.All the necessary training actions were carried out for patients and relatives by the pharmacoepidemiology network.All the patients participated in the presentation of the product by the firm.Also there was a training given to municipal pharmacoepidemiologists, hospital pharmacists and community pharmacies responsible for dispensing the device and the penfill.Manufacturer's comment / company comment: (b)(6)2018 : as the device novopen 4 has not been returned to novo nordisk a/s for investigation and very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case 584858.In this case the reported events diabetic ketoacidosis, hyperglycaemia, device failure and wrong technique in product usage process are assessed as listed; urinary tract infection is assessed as unlisted according to the novo nordisk current ccds in actrapid and insulatard.Diabetic ketoacidosis and hyperglycaemia could have been triggered by urinary tract infection.However,more details are needed for the proper medical evaluation.This single case report is not considered to change the current knowledge of the safety profile of actrapid and insulatard.
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