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| Model Number N/A |
| Device Problems
Labelling, Instructions for Use or Training Problem (1318); Device Difficult to Setup or Prepare (1487); Device Operates Differently Than Expected (2913)
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| Patient Problems
Hyperglycemia (1905); Diabetic Ketoacidosis (2364)
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| Event Date 10/11/2017 |
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Event Type
Injury
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Event Description
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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 case received via "ministry of (b)(6)" from (b)(4) 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, dose and frequency unknown", insulatard penfill (insulin human) from unknown start date and ongoing for unknown indication, dose and frequency unknown.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)(6) (same reporter).Company comment: in this case the reported events are listed.More details are needed for the proper medical evaluation.Reporter comment: (b)(4) classified the events as related to novopen 4, not to the insulins (actrapid and insulatard).
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Event Description
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Case description: investigation result: name: novopen 4, batch number: unknown, no investigation was possible, because neither sample nor batch number was available.Name: insulatard penfill 100 iu/ml, batch number: fs61b38, the complaint had been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.The product was not returned for examination.Since last submission this case has been updated with the following: investigation result updated, manufacturer comment added, narrative updated accordingly.Manufacturer's / company comment: 19-mar-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 (b)(4).In this case the reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of actrapid and insulatard.Evaluation summary: name: novopen 4, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.
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Event Description
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Case description: investigation result: novopen 4, batch: fvg9876-1.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The piston rod was normal.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Novopen 4, batch: fvg9827-1.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The piston rod was normal.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Insulatard penfill 100 iu/ml, batch number: fs61b38.The complaint had been registered in the novo nordisk complaint handling system and a medical evaluation has been performed.The product was not returned for examination.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.No further information available.Since last submission this case has been updated with the following investigation result updated for both novopen 4.Narrative updated accordingly.Manufacturer's comment updated.Manufacturer's / company comment: 08-aug-2018: since no faults were found on the returned devices of novopen 4 (batch nos- fvg9827-1 and fvg9876-1) and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event and thus not possible to find similar incidents to the one reported in (b)(4).In this case the reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of actrapid and insulatard.Otc selected for novopen 4, batch fvg9827-1, due to esubmitter limitation.Evaluation summary: novopen 4, batch: fvg9827-1.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The piston rod was normal.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.
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Event Description
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Case description: this serious regulatory authority spontaneous case from cuba was reported via "ministry of health (cecmed)" initially by a consumer and medically confirmed by health care professional nos as "diabetic ketoacidosis" beginning on (b)(6) 2017, "hyperglycaemia" beginning on (b)(6) 2017, "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 16 years old female patient who was treated with novopen 4 (insulin delivery device; batch number fvg9827 -1) from unknown start date due to "diabetes mellitus", novopen 4 (insulin delivery device; batch number fvg9876-1) from unknown start date due to "diabetes mellitus", insulatard penfill (insulin human) from (b)(6) 2017 due to "diabetes mellitus" (dose and frequency 4 iu, qd) and actrapid penfill (insulin human) from (b)(6) 2017 due to "diabetes mellitus" (dose and frequency 24 iu, qd).Patient's weight: 42.5 kg.Patient's height and body mass index were not reported.Weight in section a.4.Has been rounded to a whole number due to esubmitter limitation with decimal.Medical history included diabetes mellitus (type and duration: not reported).Treatment included - cimetidine (cimetidine), insulin.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.On (b)(6) 2017, the patient experienced nausea and discomfort in the stomach for which the patient's mother medicated her at home with 1 tab of cimetidine.It was reported that the patient had diabetic ketoacidosis, a few days after the patient started using penfill and novopen 4.On (b)(6) 2017, the patient continued with discomfort.On (b)(6) 2017, the patient presented epigastric pain of moderate intensity, nausea, decay and begins with vomiting in the house 4 times after the administration of the actrapid dose in the morning.The mother transferred her to hospital where she had glycaemia levels of 27.3 mmol/l (hyperglycaemia) and was administered 10iu of insulin.The patient had moderate dehydration, decreased eyeballs and respiratory rate in 26 (unit: not reported).The patient was admitted to intensive therapy reported as serious condition.On (b)(6) 2017, the patient's po2 (partial pressure of oxygen) was 95.1 mmhg, pco2 (partial pressure of carbon dioxide) was 21.9 mmhg, ph was 7.25 ph, choco3st (non-codable) was 12.6 mmol/l, blood glucose was 24.7 mmol/l at 09:00 am and 5.8 mmol/l at 12:00 pm.On (b)(6) 2017 at 04:00 am, the patient's blood glucose was 3.1 mmol/l.Now the patient administered the medication by herself and took it to school inside the lunch case at room temperature.The patient complied with the mechanism of air expulsion before administration, counted 6 seconds before removing the needle and did not determine the glucose before administering the medication because her glucometer was broken.The mother reported that she was compensated until she began to use the new insulins.Action taken to insulatard penfill was reported as product discontinued.Action taken to actrapid penfill was reported as product discontinued.Action taken to novopen 4 was not reported.Action taken to novopen 4 was not reported no further information available.Since last submission this case has been updated with the following -case was medically confirmed with health care professional as reporter -batch number for novopen 4 updated (fvg9827 -1 and fvg9876-1) -seriousness criteria for events diabetic ketoacidosis, device failure and hyperglycaemia updated.-medical history updated.-patient's age and weight added.-onset date for the event diabetic ketoacidosis was added -start date, stop date route of administration, indication, dose and action take was updated for the suspected products insulatard and actrapid.-treatment medication cimetidine added -treatment received for the event "diabetic ketoacidosis" was captured as yes.-lab data updated.-reporter'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.
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