(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 flush the l-6 line to remove the obstruction.There were no further reports of errors and the instrument was reported to be working fine.No further action was required by field service.The most probable cause of the reported event was due to a clog in the l-6 line.
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On (b)(6) 2017, the customer reported "high pressure grad sensor" error with their g8 analyzer.The customer replaced the column, changed the filter and rebooted from main power; however, pressure remained high.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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