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(related symptoms if any separated by commas): unconscious due to severe hypoglycemia [hypoglycaemic unconsciousness], dose scale isn't clear and the piston rod moved [device malfunction], hyperglycemia 400 mg/dl [hyperglycaemia].Case description: study id: (b)(6).Study description: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.Patient's height: 165 cm.Patient's weight: (b)(6) kg.Patient's bmi: 25.71166210.This serious solicited report from egypt was reported by a consumer as "unconscious due to severe hypoglycemia(hypoglycemic unconsciousness)" beginning on 2020 , "dose scale isn't clear and the piston rod moved (device component malfunction)" with an unspecified onset date , "hyperglycemia 400 mg/dl(hyperglycemia)" beginning on 2020 and concerned a (b)(6) year-old male patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "diabetes mellitus" and mixtard 30 hm penfill (insulin human) suspension for injection, 100 iu/ml (dose, frequency & route used - 50 iu, qd (30-0-20), subcutaneous) from unknown start date and ongoing for "diabetes mellitus", dosage regimens: novopen 3: mixtard 30 hm penfill: 50iu, qd; 40iu, qd; 50iu, qd.Current condition: diabetes mellitus (type not reported and duration since 20 years), psychosis, diabetic retinopathy.Historical condition: hypoglycemia.Concomitant medications included - depakene [valproic acid] (valproic acid), prozac(fluoxetine hydrochloride), risperidone, vitamin b6, vitamin b 12 [vitamin b12 nos] (vitamin b12 nos) ongoing.Treatment medications included - glucose.On an unknown date of 2020 (reported as 1.5 months ago), patient became unconscious due to severe hypoglycemia and was taken to a hospital.It was reported that patient's novopen 3 dose scale was not clear and the piston rod moved.Patient reported that technical complaints with novopen 3 could have caused hypoglycemic unconsciousness.Patient suspected that the unclear dose scale numbers of the np3 might contribute the occurrence of the event hypoglycemic unconsciousness as he might have taken a wrong dose.Patient was given glucose solution and recovered on the same day.The dose of mixtard then decreased as a sequence with hypoglycemia and the patient suffered from hyperglycemia 400 mg/dl 3 days after the onset date of hypoglycemia so the dose increased again.On an unknown date of 1.5 or 2 years back, the patient had hypoglycemia, and the patient follow excessive exercise , didn't have as suitable a meal , and took insulin dose and recovered once had the meal without hospitalization.Batch numbers: novopen 3: nscg181.Mixtard 30 hm penfill: kr73e85, kr73e85, kr73e85; action taken to mixtard 30 hm penfill was reported as dose decreased.On an unknown date of 2020 the outcome for the event "unconscious due to severe hypoglycemia (hypoglycemic unconsciousness)" was recovered.The outcome for the event "dose scale isn't clear and the piston rod moved (device component malfunction)" was not reported.The outcome for the event "hyperglycemia 400 mg/dl(hyperglycemia)" was not reported.Reporter's causality (novopen 3) - unconscious due to severe hypoglycemia (hypoglycemic unconsciousness) : possible dose scale isn't clear and the piston rod moved (device component malfunction) : possible hyperglycemia 400 mg/dl(hyperglycemia) : unknown.Company's causality (novopen 3) - unconscious due to severe hypoglycemia (hypoglycemic unconsciousness) : possible dose scale isn't clear and the piston rod moved (device component malfunction) : possible hyperglycemia 400 mg/dl(hyperglycemia) : unlikely.Reporter's causality (mixtard 30 hm penfill) - unconscious due to severe hypoglycemia (hypoglycemic unconsciousness) : probable dose scale isn't clear and the piston rod moved (device component malfunction) : unknown hyperglycemia 400 mg/dl(hyperglycemia) : unknown.Company's causality (mixtard 30 hm penfill) - unconscious due to severe hypoglycemia(hypoglycemic unconsciousness) : possible dose scale isn't clear and the piston rod moved(device component malfunction) : possible hyperglycemia 400 mg/dl(hyperglycemia) : unlikely.In order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the medical device).The disassembled medical device will be stored with the same retention period as other complaint samples.References included: reference type: e2b company number reference id#: eg-novoprod-770650 reference notes: company comment: hypoglycemic unconsciousness is assessed as listed according to the novo nordisk current ccds information on mixtard 30 hm penfill.Considering the positive temporal association, action taken with mixtard 30 hm penfill, recovery of the event after treatment and pharmacological property of mixtard 30 hm penfill, causal relationship cannot be denied.Patient's underlying medical condition of type2 diabetes mellitus, titration of insulin dosage to treat hyperglycaemia and concomitant use of anti-psychotic medications is a significant confounding factor for the development of hypoglycaemia and its complications.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 hm penfill.Preliminary manufacturer's comment: 09-dec-2020: the suspected device novopen 3 has not been returned to novo nordisk for evaluation.No conclusion has been reached.Patient's underlying medical condition of type2 diabetes mellitus, titration of insulin dosage to treat hyperglycaemia and concomitant use of anti-psychotic medications is a significant confounding factor for the development of hypoglycaemia and its complications.Reporter comment: anti-psychotic drugs may be one of the etiology of hypoglycemia.Additional dosage regimens: suspect product: 2.Dose, frequency & route used, 3.Therapy dates (if unknown, give duration) 6.Lot # 7.Exp.Date: #1 mixtard 30 penfill hm(ge) 3.0 ml regimen # 2 40 iu, qd (25-0-15) decreased dose, subcutaneous kr73e85 07/--/2022; #1 mixtard 30 penfill hm(ge) 3.0 ml regimen # 3 50 iu, qd (30-0-20), subcutaneous ongoing kr73e85 07/--/2022.
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Case description: investigation results.Name: novopen® 3: batch nscg181: the product was not returned for examination.The pen was produced in 2003 it was not possible to investigate the batch documentation as the pen was 17 years old and therefore no longer available.Name: mixtard® 30 penfill® 3 ml 100iu/ml: batch kr73e85: the product was not returned for examination.A reference sample was examined macroscopically, microscopically and analysed chemically.The reference sample was found to be normal.The results were found to comply with specifications.During investigation no irregularities related to the complaint was detected on a reference/reserve sample of the batch in question.Since last submission, the following has been updated in the case (not yet submitted) -investigation results updated -annex b,c,d and g updated.-manufacturer's comment updated.-narrative updated accordingly.References included: reference type: e2b company number reference id#: (b)(4).Reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2020-00063.Reference notes: medwatch 3500a mfr.Report number.Final manufacturer's comment: 01-feb-2021: the suspected device novopen 3 has not been returned to novo nordisk for evaluation.The pen is produced in 2003.It is not possible to investigate the batch documentation as the pen is 17 years old and there-fore no longer available.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse event.Patient's underlying medical condition of type2 diabetes mellitus, titration of insulin dosage to treat hyperglycaemia and concomitant use of anti-psychotic medications is a significant confounding factor for the development of hypoglycaemia and its complications.Company comment: hypoglycemic unconsciousness is assessed as listed according to the novo nordisk current ccds information on mixtard 30 hm penfill.The suspected drug mixtard® 30 penfill has not been returned to novo nordisk for evaluation.The batch documentation has been reviewed and found to be normal.No abnormalities relating to the observed problem were found.A reference sample was examined macroscopically and analysed chemically.The reference sample was found to be normal.Patient's underlying medical condition of type2 diabetes mellitus, titration of insulin dosage to treat hyperglycaemia and concomitant use of anti-psychotic medications is a significant confounding factor for the development of hypoglycaemia and its complications.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 hm penfill.H3 continued: evaluation summary: investigation results: name: novopen® 3.Batch nscg181.The product was not returned for examination.The pen was produced in 2003 it was not possible to investigate the batch documentation as the pen was 17 years old and therefore no longer available.
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Case description: investigation results.Novopen 3 - batch nscg181.Visual examination and functional testing 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 and the piston rod movement was normal.However, a part of the push-button was broken off during use.The observed problem with the push-button was a result of accidental damage during use.Also, the print on the dose indicator barrel was difficult to read.The fault might occur due to wear when touching the dose indicator barrel instead of only the dosage selector when selecting a dose.The fault might also be caused by accumulation of foreign matter on the dose indicator barrel.The fault was caused by accidental damage/ wear during use.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.Since last submission, the following has been updated in the case (not yet submitted) -investigation results updated for novopen 3 device available for evaluation and date returned to manufacturer was updated malfunction field under device information is updated from "yes" to "no"."is non reportable" updated from "no" to "yes".-annex b, c, d, codes were updated to new codes.-manufacturer's comment updated.-narrative updated accordingly.Final manufacturer's comment: 22-jun-2021: the suspected device novopen 3 has been returned to novo nordisk for evaluation.The pen is produced in 2003.Upon examination of pen, it was found that push button broken off during use.The root cause is handling during use, when the pen has been dropped on a hard surface or the like.Also print on the dose indicator barrel is difficult to read.The fault may be caused by accumulation of foreign matter on the dose indicator barrel.These user errors will not have any impact on the functionality of the device.Patient's underlying medical condition of type2 diabetes mellitus, titration of insulin dosage to treat hyperglycaemia and concomitant use of anti-psychotic medications is a significant confounding factor for the development of hypoglycaemia and its complications.H3 continued: evaluation summary.Investigation results.Novopen 3 - batch nscg181.Visual examination and functional testing 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 and the piston rod movement was normal.However, a part of the push-button was broken off during use.The observed problem with the push-button was a result of accidental damage during use.Also, the print on the dose indicator barrel was difficult to read.The fault might occur due to wear when touching the dose indicator barrel instead of only the dosage selector when selecting a dose.The fault might also be caused by accumulation of foreign matter on the dose indicator barrel.The fault was caused by accidental damage / wear during use.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.
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