(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On 05-jun-2017, fse arrived at the site to address the reported event.Inspection of the device revealed a clog in line #6 at the injector valve.Fse replaced line #6, and the stator face & rotor seal as a precaution.No further issues were reported and no further action was required by field service.The most probable cause of the reported event was due to clogged line #6.
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On (b)(6) 2017, the customer reported high pressure with their g8 analyzer.She changed the column and filter prior to calling technical support (ts).Ts instructed the customer to check the pressure without the filter.The customer subsequently received a "grad sens error 150".On (b)(4) 2017, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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