Event verbatim [preferred term] (related symptoms if any separated by commas) the patient was hospitalized to regulate blood glucose.[blood glucose abnormal] novopen 4 could be pushed.No medication liquid came out.[device failure] case description: this serious spontaneous case from china was reported by a consumer as "the patient was hospitalized to regulate blood glucose.(blood glucose abnormal)" with an unspecified onset date, "novopen 4 could be pushed.No medication liquid came out.(device failure)" with an unspecified onset date, and concerned a (age not reported) male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", novomix 30 penfill (insulin aspart, insulin aspart protamine) (dose, frequency & route used- 28 iu, qd (14 u in the morning and 14 u in the evening)) from unknown start date for "type 2 diabetes mellitus".Patient's height, weight and body mass index was not reported dosage regimens: novopen 4: novomix 30 penfill: current condition: type 2 diabetes mellitus.(for over 10 years(the patient did not remember the specific year when the disease was diagnosed) concomitant products included - atorvastatin on an unknown date, the novopen 4 could be pushed.No medication liquid came out, and the patient was hospitalized to regulate blood glucose for 7 days(patient did not remember the specific dates) on an unknown date, the patient called the hotline and the hotline guided the handling, the rubber plunger of the penfill was close to the top of the piston rod.The medication liquid came out normally after the needle was installed.The patient accepted that and was trained on the use of the product.The patient did not suspect the product quality.The malfunction was removed successfully.Batch numbers: novopen 4 and novomix 30 penfill: were requested action taken to novopen 4 was not reported.Action taken to novomix 30 penfill was reported as product discontinued due to ae.The outcome for the event "the patient was hospitalized to regulate blood glucose.(blood glucose abnormal)" was not reported.On 05-feb-2024 the outcome for the event "novopen 4 could be pushed.No medication liquid came out.(device failure)" was recovered.
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Case description: investigation results: novopen 4 - bathch number: unknown no investigation was possible, because neither sample nor batch number was available.Novomix 30 penfill - batch number: unknown no investigation was possible, because neither sample nor batch number was available.Since last submission case has been updated with flowing information, -investigation results updated for novopen 4 and novomix 30 penfill -device addendum tab and eu-ca tab updated -narrative updated accordingly.Final manufacturer's comment: 27-mar-2024: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.Batch number of the device unavailable despite repeated efforts to find the same.No batch trend analysis or reference sample analysis performed.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 4.Patient's underlying medical condition of type 2 diabetes mellitus is a significant confounding factor for the development of reported events.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of novomix 30 penfill.H3 continued: evaluation summary no investigation was possible, because neither sample nor batch number was available.
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