Severe hypoglycaemia [hypoglycaemia].Novopen 4 over delivering the insulin dose that was delivered with the priming dose [incorrect dose administered by device].Case description: this serious spontaneous case from (b)(6) was reported by a diabetes nurse specialist as "severe hypoglycaemia" beginning on (b)(6) 2018, "novopen 4 over delivering the insulin dose that was delivered with the priming dose" beginning on (b)(6) 2018, and concerned a 9 years old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus".Patient's height: 146 cm; patient's weight: (b)(6); patient's bmi: 18.296.Medical history included type 1 diabetes mellitus (recent diagnosis entering honeymoon phase).Concommitant medication included - lantus junior star pen (non-codable), insulin.On an unknown date in 2018, the mother of the patient changed the cartridge into a novopen 4 and primed the pen and was surprised at the force of insulin that was delivered with the priming dose.The mother then dialled up the dose and administered.On (b)(6) 2018, the patient experienced severe hypoglycaemia requiring admission to hospital in an ambulance.It was presumed that, the hypoglycaemia was due to the pen over delivering an insulin dose.The patient was discharged in (b)(6) 2018.Information on batch number was not provided.Action taken to novopen 4 was product discontinued.On (b)(6) 2018 the outcome for the event "severe hypoglycaemia" was recovered with sequelae.The outcome for the event "novopen 4 over delivering the insulin dose that was delivered with the priming dose" was not reported.Investigation result: product: novopen 4; batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Manufacturer's comment: on 24-jul-2018: as the device novopen 4 has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4).Evaluation summary: investigation result; product: novopen 4, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.
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