(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, an fse visited the customer to address the reported event.During servicing, fse verified the system and found a semi clogged purge check valve.Fse then flushed the valve and verified proper pressure.Fse ran controls and the instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event was due to a clogged check valve.
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On (b)(6) 2016, a customer reported they are getting high pressure errors with their g8 analyzer.The customer tried replacing the prefilter and the column, the high pressure errors persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hga1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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