(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) 2017, fse conducted follow-up with the customer over-the-phone to address the reported event.Fse performed troubleshooting with the customer to remove the prefilter and run the pump.The device did not alarm.Next, she replaced the column and prefilter and was able to successfully run several patient samples with good results.No further action was required by field service.The most probable cause of the reported event was due to a clogged l-6 line.
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On (b)(6) 2017, the customer reported high pressure alarms with their g8 analyzer.The customer attempted to troubleshoot by replacing the filter and column and repowering the device.The device also sounded high pressure alarms during the pressure test.On (b)(6) 2017 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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