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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] 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 (b)(6) 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) solution for injection, 100 iu/ml (dose, frequency & route used- unk (according to what the patient will eat), subcutaneous) from 2014 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", the patient's height, weight and body mass index was not reported.Dosage regimens: novopen 5: not reported novopen: not reported novorapid penfill: not reported to not reported (dosage regimen ongoing); tresiba penfill: (b)(6) 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.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 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.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.Batch numbers: novopen 5: unknown novopen : 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 novopen was not reported.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.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: -novopen added as a suspect -start date of novopen 5, novopen and novorapid penfill updated -device tab, eu/ca tab and device addendum tab updated -narrative updated accordingly final manufacturer's comment: (b)(6) 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.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 (b)(6) 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.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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