(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) 2016, fse conducted follow-up with the customer over-the-phone to address the reported event.Fse performed troubleshooting with the customer to review areas of potential leaks.Inspection of the device did not reveal any leak.Fse notified the customer that they would come to the site the next day to perform drain flushes on the device.On (b)(6) 2016, the customer called and cancelled the service call.Fse called the customer back to verify that the device was running properly.They customer stated that after extra priming and drain flushes the issue had resolved.No further action was required by the field service.The most probable cause of the reported event was due to air in the system.
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On (b)(6) 2016, the customer reported low pressure mid-run with their g8 analyzer.The customer performed four drain flushes but the pressure remained at zero.Technical support (ts) had the customer verify all the connections were secure and that all buffers were full.No issues were noted.Next, ts instructed the customer to turn on the pump.There were no changes to the device pressure.Finally, the customer opened & closed the drain valves but the pressure remained at zero.On (b)(6) 2016, 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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