Event verbatim [preferred term] (related symptoms if any separated by commas).Serious glycaemic decompensations [diabetic metabolic decompensation] novo pen echo and novo pen echo plus that were not dosing the right amounts of insulin [device delivery system issue].Displaying errors on the pens [device information output issue].Insulin vials are not protected at all and keep on breaking the moment the pen falls on the ground [device issue].Case description: this serious spontaneous case from poland was reported by a physician as "serious glycaemic decompensations(diabetic metabolic decompensation)" with an unspecified onset date, "novo pen echo and novo pen echo plus that were not dosing the right amounts of insulin(inaccurate delivery by device)" with an unspecified onset date, "displaying errors on the pens(device image display error)" with an unspecified onset date, "insulin vials are not protected at all and keep on breaking the moment the pen falls on the ground(device component issue)" with an unspecified onset date, and concerned a (age not reported) female patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", tresiba penfill 100 u/ml (insulin degludec) (dose, frequency & route used- unk, subcutaneous) from unknown start date for "type 1 diabetes mellitus", fiasp penfill (insulin aspart) (dose, frequency & route used- unk, subcutaneous) from unknown start date for "type 1 diabetes mellitus".The patient's height, weight and body mass index (bmi) were not reported.Current condition: diabetes mellitus type 1(duration was not reported).On an unspecified date, patient change the insulin pump treatment back to the multi-injection pen therapy using the insulin fiasp , tresiba and the novopen echo and novopen echo plus pens.Pen was used by the patient for some months.On an unspecified date, patient experienced some serious glycaemic decompensations over weeks.It was reported that patient encountered many problems concerning use of novopen echo and novopen echo plus pens.Due to faulty novo pen echo and novo pen echo plus device , pen were not dosing the right amounts of insulin and later on displaying errors on the pens themselves.It was reported that the insulin vials are not protected at all and keep on breaking the moment the pen falls on the ground (which in her opinion was not the case at all in the pens novo nordisk offered 10-20 years ago).Batch numbers: novopen echo plus: unknown novopen echo: unknown tresiba penfill 100 u/ml: asku fiasp penfill: asku.Action taken to novopen echo plus was reported as product discontinued.Action taken to novopen echo was reported as product discontinued.Action taken to tresiba penfill 100 u/ml was reported as unknown.Action taken to fiasp penfill was reported as unknown.The outcome for the event "serious glycaemic decompensations(diabetic metabolic decompensation)" was unknown.The outcome for the event "novo pen echo and novo pen echo plus that were not dosing the right amounts of insulin(inaccurate delivery by device)" was not reported.The outcome for the event "displaying errors on the pens(device image display error)" was not reported.The outcome for the event "insulin vials are not protected at all and keep on breaking the moment the pen falls on the ground(device component issue)" was not reported."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".
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Case description: investigation result: name novopen® echo® plus batch no: mvg9a73.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.Name:novopen echo® batch no: unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.References included: reference type: (b)(4).Reference id#: pl-novoprod-(b)(4).Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2024-00037.Reference notes: medwatch 3500a mfr.Report number.Reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2024-00038.Reference notes: medwatch 3500a mfr.Report number.H3 continued: evaluation summary: name novopen® echo® plus batch no: mvg9a73.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.
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