An fse visited the customer to address the reported event.During servicing,fse replaced buffer solenoid valve #2.The instrument was verified as operational.Patient sample were ran with good chromatography.There was no further action required by fse.The most probable cause of the reported event was failure of the buffer #2 solenoid valve.(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).
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On (b)(6) 2015, a customer reported low pressure with their g8 analyzer a field service engineer (fse) was dispatched on (b)(6) 2015 to address the reported event,which resulted in delay in reporting of patient results hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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