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Event verbatim [preferred term] (related symptoms if any separated by commas) 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) 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 patients 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 patients 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.(b)(4).Company comment: in this case the reported events are listed.More details are needed for the proper medical evaluation.Reporter comment: the moh 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) urinary infection [urinary tract infection] multiorgan failure [multiple organ dysfunction syndrome] 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] hypoglycemia [hypoglycaemia] case description: this serious spontaneous regulatory authority case received via "ministry of health (cecmed)" from cuba was initially reported by a consumer and later confirmed by health care professional as "urinary infection" beginning on (b)(6)2017 , "multiorgan failure" beginning on (b)(6)2017 , "diabetic ketoacidosis" beginning on (b)(6)2017 , "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, "hypoglycemia" beginning on (b)(6)2017 and concerned a 14 years old female patient who was treated with two novopen 4 (insulin delivery device) from unknown start date due to "diabetes mellitus", actrapid penfill (insulin human) from (b)(6)2017 to (b)(6)2017 due to "diabetes mellitus" (dose and frequency 8 qd), insulatard penfill (insulin human) from (b)(6)2017 to (b)(6)2017 due to "diabetes mellitus" (dose and frequency 2 iu, qd).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: 40 kg patient's height and body mass index were not reported.Medical history included diabetes mellitus (type and duration not reported) and diabetic hepatopatia (for 7 years).On (b)(6)2017 , the patient started treatment with actrapid and insulatard.On (b)(6)2017 , the patient experienced hypoglycaemia in the early morning in the school after administration of the first dose of actrapid.On the same day, the patient had insulatard before bedtime.On (b)(6)2017 , in the early hours, the patient began vomiting 5 times and threw all the food, and then the patient began with shortness of breath which was increasing.The patient also had abdominal pain at the level of epigastrium of moderate intensity.On the morning of (b)(6)2017 , before leaving home, the patient's blood glucose was 32 mmol/l.The patient was transferred to the hospital where she began with incoherent language.At the hospital, the patient denied fever that soon presented while on therapy and pain when urinating.The patient was entered with septic shock in intensive therapy with diagnosis of diabetic ketoacidosis, urinary infection and multiorgan failure.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.One of the six patient noticed during the air test, that the medication did not come out because the pen was stuck.It was reported that 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.Also, it was reported that the patient did not follow the instructions in the insert regarding testing the insulin flow before injecting the insulin.On an unspecified date, the patient recovered from hyperglycaemia and diabetic ketoacidosis and then the device was changed and the patient was retrained in the use of penfill and novopen 4.The mother of the patient reported that the patient administered the medication alone and took it to school inside the lunch case at room temperature; complied with the air ejection mechanism before administration, counted 6 seconds before removing the needle and always determined the glucose before administering the medication.The mother reported that she was compensated until she started using the new insulins.It was reported that the patient was in critical condition, with multiple organ failure, edema and peritoneal dialysis.The patient also had elevated level of transaminase.Of note, all the patients were trained before changing the form of administration (place: summer camps).At the time of delivery of the device in the hospital pharmacy, both the patient and the family received training for the use of the device by the licensees in charge.The device was never delivered to relatives if the patients were not present (second training) during the follow-up of patients until discharge, they were visited daily in the different services to verify their evolution and if it was possible to verify with each one of them the status of each device in a personal way and the mastery of the techniques of use, of practical way (monitoring).On an unknown date, 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 patients used insulin suspension and stated that they always performed the re-suspension because they know it was the same type of insulin.There were no changes reported in diet.It was also reported that knowledge was shared related to the needle insertion angle and needle was inserted into the pen at a 180 degree 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 carried to the school, or keeping it in cool place at home.All the diagnoses of ketoacidosis were issued by specialists in the hospital.Action taken to both novopen 4 was not reported.Action taken to actrapid penfill was not reported.Action taken to insulatard penfill was reported as product discontinued due to ae (adverse event) the outcome for the event "urinary infection" was not reported.The outcome for the event "multiorgan failure" was not yet recovered.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, medication did not come out because the pen was stuck." 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.The outcome for the event "hypoglycemia" was not reported.No further information available investigation result: name: novopen® 4 - batch fvg9827-1 the product was not returned for examination.A batch trend analysis was performed, nothing abnormal found.The complaint has been registered in the novo nordisk complaint handling system.Name: novopen® 4 - batch fvg9876-1 the product was not returned for examination.A batch trend analysis was performed, nothing abnormal found.The complaint has been registered in the novo nordisk complaint handling system name: actrapid® penfill® 100 iu/ml - batch fs61b39 name: 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.Reporter's comment: the moh classified the events as related to novopen 4, not to the insulins (actrapid and insulatard).No patient and family member reported that they had to make a different force to inject, making it easy to operate the dose button 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 penfill, 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.It was reported that the patients were all trained, as well as the family members, 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 it was informed 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 reported that several of the patients had received a first training months before, during their participation in the camp for diabetic children organized and directed by the head of endocrinology, 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.All the necessary training actions were carried out for patients and relatives by the pharmacoepidemiology network, taking into account that as representative, 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.Since last submission, the case has been updated with the following: -start date, stop date, dose, frequency, route used and indication of insulatard and actrapid was updated -action taken to insulatard updated as product discontinued due to ae -seriousness criteria of hospitalization added to the event of "diabetic ketoacidosis" and onset date updated as (b)(6)2017 -seriousness criteria of hospitalization updated for events hyperglycaemia and device failure based on follow-up information.-additional events of "urinary infection", "multiorgan failure" and "hypoglycaemia" were added -patient codes updated -patient age and weight were updated -medical history of diabetes mellitus and diabetic hepatopatia updated -blood glucose and transaminases updated in laboratory data -device manufacture and expiration dates added -usage of device updated -batch number of novopen 4 added (fvg9827-1, fvg9876-1).-indication of novopen 4 updated as diabetes mellitus -investigation result updated.-hcp added as reporter.-reporter's comment updated -manufacturer's comment updated.-narrative updated accordingly.Manufacturer's comment/company comment: (b)(6)2018: as the devices of novopen 4 have 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 (b)(4).In this case the reported events diabetic ketoacidosis, hyperglycemia, device failure, wrong technique in product usage process and hypoglycemia are assessed as listed; urinary tract infection and multi organ failure are assessed as unlisted events according to the novo nordisk current ccds in actrapid and insulatard.Diabetic ketoacidosis and hyperglycaemia could have been triggered by urinary tract infection in this patient.This patient possibly developed complications such as urinary sepsis leading to multiple organ failure.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.H3 continued: evaluation summary name: novopen 4-batch fvg9827-1 the product was not returned for examination.A batch trend analysis was performed, nothing abnormal found.The complaint has been registered in the novo nordisk complaint handling system.
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