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Event verbatim [preferred term] (related symptoms if any separated by commas).Ketoacidosis [ketoacidosis].Problem with the threaded rod [device issue].Did not get insulin any more [device failure].Sugar kept going up and down (blood sugar fluctuations) [blood glucose fluctuation].Continued to inject with the pens without returning the threaded rod to its original position [wrong technique in device usage process].Case description: this serious spontaneous case from switzerland was reported by a other health care professional as "ketoacidosis(ketoacidosis)" beginning on 31-mar-2023, "problem with the threaded rod(device component issue)" with an unspecified onset date, "did not get insulin any more(device failure)" with an unspecified onset date, "sugar kept going up and down (blood sugar fluctuations)(blood glucose fluctuation)" with an unspecified onset date, "continued to inject with the pens without returning the threaded rod to its original position(wrong technique in device usage process)" with an unspecified onset date, and concerned a 77 years old female patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "device therapy", novopen 3 (insulin delivery device) from unknown start date for "device therapy".Medical history was not provided.On an unknown date, the patient opened both novopens 3 at home and noticed that there was a problem with the threaded rod.Patient is not technically experienced and needs support from spouse in technical matters.The threaded rod of both pens went into the 0 position.Patient did not change cartridges and continued to inject insulin (unspecified) with the pens without returning the threaded rod to its original position.No function test carried out.The patient did not get insulin any more and on 31-mar-2023, derailed with the blood sugar.On 31-mar-2023, the patient was admitted to the intensive care unit with ketoacidosis for 5 days and then 2 days in normal ward.On an unknown date, recently, the sugar kept going up and down (blood sugar fluctuations).After getting better, patient started injecting insulin herself again with these pens.Sometimes the icu staff also injected the insulin with a classic syringe.Reporter stated that it seemed that patient did not respond to the insulin at times.The patient was switched to the flextouch pre-filled pen so that the problem could no longer occur.Can occur again.Batch numbers of novopen3 requested.The outcome for the event "ketoacidosis(ketoacidosis)" was recovered.The outcome for the event "problem with the threaded rod(device component issue)" was not reported.The outcome for the event "did not get insulin any more(device failure)" was not reported.The outcome for the event "sugar kept going up and down (blood sugar fluctuations)(blood glucose fluctuation)" was unknown.The outcome for the event "continued to inject with the pens without returning the threaded rod to its original position(wrong technique in device usage process)" was not reported.Preliminary manufacturer's comment: 19-apr-2023: the suspected device novopen 3 has not been returned to novo nordisk for evaluation.No conclusion is reached.Patient is not a trained user of device.Elderly age of the patient (77 years) is a significant confounding factor.Wrong technique in device usage process can affect the functionality of device, resulting in hyperglycaemia and its complications.
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Case description: investigation result.Name novopen 3 (1) batch no: unknown.No investigation was possible, because neither sample nor batch number was available.Name novopen 3 (2) batch no: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the following; investigation result added.Imdrf code added.Relevant fields updated in eu/ca tab.Narrative updated accordingly.Final manufacturer's comment: 02-jun-2023: the suspected device novopen 3 has not been returned to novo nordisk for evaluation.Batch number of the device unavailable despite repeated efforts to find the same.No batch trend analysis or reference sample analysis performed.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 3.Patient is not a trained user of device.Elderly age of the patient (77 years) is a significant confounding factor.Wrong technique in device usage process can affect the functionality of device, resulting in hyperglycaemia and its complications.Company comment: diabetic ketoacidosis is assessed as listed event according to novo nordisk current reference safety information on novorapid.Medical history of diabetes, elderly age and wrong technique in product usage process are risk factors for thereported event in the patient.This single case report is not considered to change the current knowledge of the safety profile of novorapid.H3 continued: evaluation summary: name novopen 3 batch no: unknown.No investigation was possible, because neither sample nor batch number was available.
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Event verbatim [preferred term] (related symptoms if any separated by commas).Ketoacidosis (diabetic patient) [diabetic ketoacidosis] continued to inject with the pens without returning the threaded rod to its original.Position [wrong technique in device usage process].Problem with the threaded rod [device issue].Did not get insulin any more [device failure].Sugar kept going up and down (blood sugar fluctuations) [blood glucose fluctuation].Case description: this serious spontaneous case from switzerland was reported by a other health care professional as "ketoacidosis (diabetic patient)(diabetic ketoacidosis)" beginning on (b)(6) 2023, "continued to inject with the pens without returning the threaded rod to its original position(wrong technique in device usage process)" with an unspecified onset date, "problem with the threaded rod(device component issue)" with an unspecified onset date, "did not get insulin any more(device failure)" beginning on (b)(6) 2023, "sugar kept going up and down (blood sugar fluctuations)(blood glucose fluctuation)" beginning on (b)(6) 2023, and concerned a 77 years old female patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "type 1 diabetes", , novopen 3 (insulin delivery device) from unknown start date for "type 1 diabetes", novorapid (insulin aspart) (dose, frequency & route used-unk) from unknown start date and ongoing for "drug use for unknown indication".Patient's height: 165 cm.Patient's weight: 84 kg.Patient's bmi: 30.85399450.Current condition: diabetes type 1 (since 1985).Concomitant products included - tresiba(insulin degludec).It was reported by the reporter that the pen was not defective in the actual sense.The patient opened both novopens 3 at home, patient is not technically experienced and needs support from spouse in technical matters.When the patient was unscrewing a needle, the bayonet catch fell open, the pen fell apart and the threaded rod fell to the 0 position.Patient did not change cartridges and continued to inject insulin (unspecified) with the pens without returning the threaded rod to its original position.No function test carried out.The patient did not get insulin anymore and on (b)(6) 2023 and derailed with the blood sugar.On (b)(6) 2023, the patient was admitted to the intensive care unit with ketoacidosis for 5 days and then 2 days in normal ward.On (b)(6) 2023, patient blood sugar(blood glucose) kept going up and down (blood sugar fluctuations).Due to insufficient insulin supply.The patient was discharged on (b)(6) 2023.Examinations: blood gas analysis showed ketoacidosis with co2 (carbon dioxide) total aterial 15.2.Mmol/l, ph(blood ph) of 7.23, phase deviation(blood gases) of 12.3 mmol/l.Blood sugar(blood glucose) was 42.2 mmol, ketone bodies(blood ketone body) test done, no values provided.The patient has been discharged a long time ago and as old as the pen was, there was nothing left of a batch number, which is not really important.The reporter reported that the current pen generation is not applicable for people who develop cognitive impairment or lack technical understanding.They will also not use or keep a user manual.With the original novo pen 1 and 2, there was a screw cap and the threaded rod had to be turned manually to the 0 position.So, no such problem was possible, no matter what the mental state or technical understanding was.You could put it back together and it worked.As described in the package insert, a function test must always be carried out.It was unfortunately often not done and as already written; these people do not take a description to hand.They can't cope with it.From the patient's point of view, these pen generations are an aggravation.But you can only recognize this if you have worked with the novo pen 1 and 2.A screw thread would bring an improvement.No information on other diseases/predisposing factors provided.No decreased efficacy of the insulin is suspected.Insulin was not administered due to lack of contact of the piston rod.The patient did not have an unexpected increase in blood glucose/insulin requirements within a short period of time (e.G., a few months).The patient had problems with the used novopen 3 device.No sulfonylureas have been taken and/or their dose reduced recently.There was no known medical history of ketoacidosis.No information if patient had recently changed her diet, her exercise level or whether skipped meals, noticed weight changes, or drank more alcohol was provided.The patient had difficulty using the suspect product.The patient did not use an already used needle and did in general not reuse the needles.She did not leave the needle attached to the pen in between injections and did not use the dialing clicks to estimate the dose of the product.No information if the force needed to inject feel different from normal (lower/easier or higher/more difficult) was provided.Batch number of novopen 3 was unknown.Novorapid: not reported.Action taken to novorapid was reported as no change.On (b)(6) 2023 the outcome for the event "ketoacidosis (diabetic patient)(diabetic ketoacidosis)" was recovered.The outcome for the event "continued to inject with the pens without returning the threaded rod to its original position(wrong technique in device usage process)" was not reported.The outcome for the event "problem with the threaded rod(device component issue)" was not reported.The outcome for the event "did not get insulin any more(device failure)" was not reported.On (b)(6) 2023 the outcome for the event "sugar kept going up and down (blood sugar fluctuations)(blood glucose fluctuation)" was recovered.Since last submission, the case has been updated with the following; patient medical history, height, weight and bmi updated novorapid added as suspect product, indication updated for novopen3, prior history for ketoacidosis updated to no.Event coding and description updated to diabetic ketoacodisis.Event onset date, stop date and outcome updated for sugar kept going up and down event stop date and outcome updated for ketoacidosis.Seriousness criteria updated to life threatening.Imdrf annexf codes updated.References included: reference type: e2b company number.Reference id#: ch-novoprod-1050220.Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2023-00056.Reference notes: medwatch 3500a mfr.Report number.Reference type: mw 3500a mfr.Rpt.# reference id#: 9681821-2023-00057.Reference notes: medwatch 3500a mfr.Report number.Preliminary manufacturer's comment: 12-may-2023: the suspected device novopen 3 has not been returned to novo nordisk for evaluation.No conclusion is reached.Patient is not a trained user of device.Elderly age of the patient (77 years) is a significant confounding factor.Wrong technique in device usage process can affect the functionality of device, resulting in hyperglycaemia and its complications.Company comment: diabetic ketoacidosis is assessed as listed event according to novo nordisk current reference safety information on novorapid.Medical history of diabetes, elderly age and wrong technique in product usage process are risk factors for the reported event in the patient.This single case report is not considered to change the current knowledge of the safety profile of novorapid.Reporter comment: it was the pen that was the problem, not the insulin.
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