(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).On (b)(6) 2015, fse conducted follow-up with the customer over the phone to address the reported event.Fse recommended they add more hemolysis wash to their working dilution.On (b)(6) 2015, fse arrived onsite to address the reported event.Fse replaced the sample loop, then verified that all the tubing and valves were clear of obstructions.Patient samples ran with normal total area.Next, fse replaced parts for the large syringe, the small syringe, and 6-way and injection valves.The injector head was cleaned and the blockage cleared.No further action was required by field service.The most probable cause of the reported event was due to an obstruction of the internal tubing.
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On (b)(6) 2015, the customer reported high total area on all controls with their g8 analyzer.All patient samples were reported to be fine.On (b)(6) 2015, a field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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