Event verbatim [preferred term] (related symptoms if any separated by commas), sugars drastically fell as unconscious within minutes [hypoglycaemic unconsciousness], pen actually giving insulin more than it said on the pen [incorrect dose administered by device], the box indicates the pen was dated 8 years ago [expired device used].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "sugars drastically fell as unconscious within minutes(hypoglycaemic unconsciousness)" with an unspecified onset date, "pen actually giving insulin more than it said on the pen(incorrect dose administered by device)" with an unspecified onset date, "the box indicates the pen was dated 8 years ago(expired device used)" with an unspecified onset date, and concerned a female patient (born in (b)(6)) who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy".Patient height, weight and body mass index not reported.Dosage regimens of novopen 5: not reported.Current condition: type 1 diabetes mellitus (duration: not reported).On an unknown date, the patient was given a novopen 5 pen by the diabetic nurse, one year ago.The box indicates the pen was dated 8 years ago.On an unknown date, the patient had two massive overdoes of insulin from pen and few days apart and patient realized it was actually giving way more insulin than it said on the pen.On an unknown date, patient gave 3 units of insulin and immediately sugars drastically fell.Pen did record 3 units but it must have been much higher as i was unconscious within minutes and ended up in hospital unconscious.It was also reported that patient use two pens and had novopen 4 and novopen 5, this is actually the second time over the years the novopen 5 has missed and gave the wrong dose.Patient reported that not recently switched from another product and it was not the first time that patient was treated and denied experiencing the same medication error in the past.Batch numbers of novopen 5: asku.Action taken to novopen 5 was not reported.The outcome for the event "sugars drastically fell as unconscious within minutes(hypoglycaemic unconsciousness)" was not reported.The outcome for the event "pen actually giving insulin more than it said on the pen(incorrect dose administered by device)" was not reported.The outcome for the event "the box indicates the pen was dated 8 years ago(expired device used)" was not reported.Preliminary manufacturer's comment: 22-jan-2021: the suspected device novopen 5 has not been returned to novo nordisk for evaluation.No conclusion is reached.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo".Reporter comment: patient's birth year was reported as (b)(6).
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Case description: investigation results: no investigation was possible, because neither sample nor batch number was available.Since last submission following has been updated: investigation results updated.Narrative updated accordingly.Final manufacturer's comment: 08-mar-2021: the suspected device novopen 5 has not been returned to novo nordisk for evaluation.Batch number of device is not available, no batch trend analysis 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, elderly age of the patient, underlying type 1 diabetes mellitus and use of expired device used are significant confounding factors which could have contributed to reported events."this report is for a foreign device that is assessed as "similar" to us marketed novopen echo".H3 continued: evaluation summary: no investigation was possible, because neither sample nor batch number was available.
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