Event verbatim [preferred term] (related symptoms if any separated by commas) the patient experienced cerebral infarction [cerebral infarction] no medication could be pushed out.[device failure] case description: this serious spontaneous case from china was reported by a consumer as "the patient experienced cerebral infarction(cerebral infarction)" with an unspecified onset date, "no medication could be pushed out.(device failure)" with an unspecified onset date, and concerned a patient who was treated with novopen (insulin delivery device) from unknown start date for "device therapy", dosage regimens: novopen: not reported medical history was not provided.On an unknown date, no medication could be pushed out by novopen.On an unknown date, the patient experienced cerebral infarction.Batch number of novopen was not obtainable.Action taken to novopen was not reported.The outcome for the event "the patient experienced cerebral infarction(cerebral infarction)" was not reported.The outcome for the event "no medication could be pushed out.(device failure)" was not reported.No further information available.
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Investigation result: novopen- batch unknown no investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with the following: investigation result was updated.Narrative was updated accordingly.References included: reference type: e2b company number reference id#: (b)(6) reference notes: reference type: mw 3500a mfr.Rpt.# reference id#: (b)(6) reference notes: medwatch 3500a mfr.Report number h3 continued: evaluation summary novopen- batch unknown no investigation was possible, because neither sample nor batch number was available.
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