H6: type of investigation code-10 investigation findings code-758 investigation conclusions -140 = bc07af per visual inspection: there is physical damage to cartridge holder, broken pocket clip and inpen front shell does not attach in place.Missing injection button was noted.The inpen paired to the commercial app.Unable to perform displacement dose accuracy, baseline and wireless functionality due to broken off injection button.Inpen passed dialing alignment using dose knob zero alignment gage.Inpen passed front cap investigation.However, inpen was received with broken cartridge holder.In conclusion: unable to confirm dose log inaccuracy due to broken off injection button making it difficult to dispense.In addition, broken pocket clip and broken cartridge holder were noted during visual inspection.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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