| Model Number N/A |
| Device Problems
Inaccurate Delivery (2339); Device Handling Problem (3265)
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| Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] (related symptoms if any separated by commas).The error almost cost the patient his life [unevaluable event].Taken 88 units of the fast-acting but should only have had 8 units (medication error) [incorrect dose administered by device].This serious spontaneous case from (b)(6) was reported by a consumer as "the error almost cost the patient his life(unevaluable event)" with an unspecified onset date, "taken 88 units of the fast-acting but should only have had 8 units (medication error)(incorrect dose administered by device)" with an unspecified onset date, and concerned a 83 years old male patient who was treated with novopen (insulin delivery device) from unknown start date for "device therapy", novorapid penfill (insulin aspart) solution for injection, 100 iu/ml from unknown start date for "drug use for unknown indication", the patient's height, weight and body mass index was not reported.Current condition: disability.Patient had two pens of the old type.The old pen delivered 88 units of the fast-acting insulin instead of 8 units and the error almost costed the patient his life.So, the patient wanted to exchange those old pens with the new pen type (with greater certainty as that would provide extra security.Batch numbers: novopen: unknown.Novorapid penfill: asku.Action taken to novorapid penfill was not reported.Action taken to novopen was not reported.The outcome for the event "the error almost cost the patient his life(unevaluable event)" was not reported.The outcome for the event "taken 88 units of the fast-acting but should only have had 8 units (medication error)(incorrect dose administered by device)" was unknown.Preliminary manufacturer's comment: the suspected device is not confirmed and has not been returned to novo nordisk for evaluation.Relevant information on medical device (novopen), user of the device, training from heal care professional on how to use /store the device, needle use are unavailable.No conclusion is reached.Company comment: unevaluable event is assessed as unlisted according to the novo nordisk current ccds in novorapid penfill (most sold product).Relevant information on medical history, clinical event due to drug over dose by device, final diagnosis, action taken and outcome of the event is unavailable for complete causality assessment.Considering the elderly age of the patient, medication administration error could have lead to life threatening event.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill (most sold product).
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Event Description
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Case description: investigation result: novopen 5 - batch unknown.No investigation was possible, because neither sample nor batch number was available.Novorapid penfill 100 e/ml 5x3 ml - batch unknown.No investigation was possible, because neither sample nor batch number was available.Tresiba penfill - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case was updated with the following: -investigation result updated.-device tab, eu/ca tab and device addendum tab updated.-narrative updated accordingly.Final manufacturer's comment: 06-sep-2021: the suspected device novopen 5 has not been returned to novo nordisk for evaluation.Batch number of device is not available, batch trend analysis or reference sample analysis was not performed.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse events.However, patient was not a trained user of the device.It is more likely that due to old age, patient got confused with novorapid and tresiba, took overdose of short acting insulin (novorapid), resulting in complication.The reported events could be attributed to product handling error.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo.H3 continued: evaluation summary.Novopen 5 - batch unknown.No investigation was possible, because neither sample nor batch number was available.
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Event Description
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Event verbatim [preferred term] (related symptoms if any separated by commas).The error almost cost the patient his life [unevaluable event].Patient did not see, that he took the wrong pen [product appearance confusion].Took 80 units of the fast-acting insulin in addition to the first 8 units [accidental overdose].Took 80 units of the fast-acting insulin instead of 80 units of tresiba [wrong product administered].This serious spontaneous case from denmark was reported by a consumer as "the error almost cost the patient his life(unevaluable event)" with an unspecified onset date, "patient did not see, that he took the wrong pen(product appearance confusion)" with an unspecified onset date, "took 80 units of the fast-acting insulin in addition to the first 8 units(accidental overdose)" with an unspecified onset date, "took 80 units of the fast-acting insulin instead of 80 units of tresiba(wrong drug administered)" with an unspecified onset date, and concerned a 83 years old male patient who was treated with novopen 5 (insulin delivery device) from unknown start date and ongoing "type 2 diabetes mellitus", novorapid penfill (insulin aspart) solution for injection, 100 iu/ml, (dose, frequency & route used from unk (according to what the patient will eat), subcutaneous) unknown start date and ongoing for "type 2 diabetes mellitus", , tresiba penfill (insulin degludec) solution for injection, 100 iu/ml (dose, frequency & route used-70 iu, qd, unknown)from 02-oct-2020 and ongoing for "type 2 diabetes mellitus".Dosage regimens: novopen 5: not reported.Novorapid penfill: not reported to not reported (dosage regimen ongoing).Tresiba penfill: 02-oct-2020 to not reported (dosage regimen ongoing).Current condition: type 2 diabetes mellitus (duration: not reported), disability, pain in feet, pain in kidney, arteriosclerosis, depression, anxiety, constipation, angina pectoris, gastric ulcer, thrombus, eye problem, pain.Family history: grandad had type 2 diabetes.Historical condition: heart attack.Concomitant products included - magnesia [magnesium oxide](magnesium oxide), laxoberal(sodium picosulfate), microlax [sodium citrate;sodium lauryl sulfoacetate](sodium citrate, sodium lauryl sulfoacetate), kaleorid(potassium chloride), farmidur(isosorbide mononitrate), venlafaxin(venlafaxine hydrochloride), eliquis(apixaban), lansoprazol, combar(mirtazapine), lyrica(pregabalin), forxiga(dapagliflozin propanediol monohydrate), panodil(paracetamol), celluvisc md(carmellose sodium), nitrolingual(glyceryl trinitrate), diural [acetazolamide](acetazolamide), oxapax(oxazepam), gangiden(macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride), morfin [morphine], nasonex(mometasone furoate), unikalk forte(calcium, colecalciferol) , nutridrik compact mixture blandet (non-codeable ( as nutrition supplement).Patient had two pens of the old type.It was reported that on an unspecified date, the patient had to take 8 units of the fast-acting insulin and 80 units of tresiba, but did not see, that he took the wrong pen (product appearance confusion).So, the patient took 80 units of the fast-acting insulin in addition to first 8 units (his regular fast acting insulin dose).So the old pen delivered 88 units of the fast-acting insulin.The patient was driven to hospital by ambulance.Patient was hospitalized due to the event.It was reported that the error almost costed the patient his life.The patient was treated at the hospital.The doctor noted that if the patient had been 20 minutes late, he would have died.The patient did not use an already used needle when experiencing the event.The patient does not store the pen with a needle attached during injections.Patient has recovered, but also feels anxiety that the event will repeat.Treatment received: the patient was treated at the hospital.Batch numbers: novopen 5: unknown.Novorapid penfill: asku.Tresiba penfill: asku.Action taken to novorapid penfill was reported as no change.Action taken to novopen 5 was reported as no change.Action taken to tresiba penfill was not reported.The outcome for the event "the error almost cost the patient his life(unevaluable event)" was recovered.The outcome for the event "patient did not see, that he took the wrong pen(product appearance confusion)" was recovered.The outcome for the event "took 80 units of the fast-acting insulin in addition to the first 8 units(accidental overdose)" was recovered.The outcome for the event "took 80 units of the fast-acting insulin instead of 80 units of tresiba(wrong drug administered)" was recovered.Since last submission, the case was updated with the following: classification of "most sold product deleted.Family history and medical history updated.Event incorrect dose administered by device deleted.3 new events added.-seriousness criteria of hospitalization added.Event outcome updated to recovered.Novpen recoded to novopen 5.Trained user checked as no for novopen 5.Novopen available for evaluation checked as yes.Suspect drug trsiba penfill added.Suspect product indication and action taken updated.Suspect product start date added and ongoing checked.Reporter causality updated from unknown to possible.Reporter comment updated.Narrative updated accordingly.Preliminary manufacturer's comment: 03-aug-2021: the suspected device novopen 5 has not been returned to novo nordisk for evaluation.Patient was not a trained user of the device.It is more likely that due to old age, patient got confused with novorapid and tresiba, took overdose of short acting insulin (novorapid), resulting in complication.It reported events could be attributed to product handling error.Company comment: unevaluable event is assessed as unlisted; product appearance confusion, accidental drug overdose and wrong product administered are assessed as listed according to the novo nordisk current ccds in novorapid penfill and tresiba penfill.Elderly age of the patient (83 years) and underlying type 2 diabetes mellitus and depression, patient was not a trained user are significant confounding factors for the development of product confusion, leading to drug over dose, wrong drug administered and hospitalised with complications.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill and tresiba penfill.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo.Reporter comment: alternative explanation: lacks control (unspecified)and clearing about date.
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Event Description
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Case description: investigation result: novopen 5 - batch unknown.No investigation was possible, because neither sample nor batch number was available.Novorapid penfill 100 e/ml 5x3 ml - batch unknown.No investigation was possible, because neither sample nor batch number was available.Tresiba penfill - batch unknown.No investigation was possible, because neither sample nor batch number was available.Novopen : unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case was updated with the following: annex b code was updated for novopen 5.Investigation result for novopen (unspecified) updated.Device tab, eu/ca tab and device addendum tab of novopen (unspecified)updated.Narrative updated accordingly.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo".
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Event Description
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Case description: this serious spontaneous case from denmark was reported by a consumer as "the error almost cost the patient his life(unevaluable event)" with an unspecified onset date, "patient did not see, that he took the wrong pen(product appearance confusion)" with an unspecified onset date, "took 80 units of the fast-acting insulin in addition to the first 8 units(accidental overdose)" with an unspecified onset date, "took 80 units of the fast-acting insulin instead of 80 units of tresiba(wrong drug administered)" with an unspecified onset date, and concerned a 83 years old male patient who was treated with novopen 5 (insulin delivery device) from 2014 for "type 2 diabetes mellitus", , novopen (insulin delivery device) from 2014 for "type 2 diabetes mellitus", , novorapid penfill (insulin aspart) from 2014 and ongoing for "type 2 diabetes mellitus", , tresiba penfill (insulin degludec) from (b)(6) 2020 and ongoing for "type 2 diabetes mellitus", patient had two pens of the old type.Pen 1 (silver) (not specified whether it is novopen).Pen 2 was a novopen 5 (blue).It was reported that the patient and the doctor agreed that the blue pen was for fast-acting insulin, and the silver pen was for long-acting insulin.It was reported that the patient injected 2 times of 40 units to get a dosage of 70-80 units of tresiba.The patient reported the cause of the event as: distraction.So, the patient wanted to exchange those old pens with the new pen type (with greater certainty as that would provide extra security.Action taken to novopen was not reported.Since last submission, the case was updated with the following: novopen added as a suspect.This report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo.Reporter comment: alternative explanation: lacks control (unspecified)and clearing about date the patient reports the cause of the event as: distraction.
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Search Alerts/Recalls
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