(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On (b)(4) 2017, fse arrived at the site to address the reported event.Fse replaced the clogged tubing from the injection valve to the line filter.Next, he calibrated, run controls, and verified proper ranges on pressure.No further errors were reported no further action was required by field service.The most probable cause of the reported event was due to clogged tubing from the injection valve to the line filter.
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On (b)(6) 2017, the customer reported receiving recurring high pressure errors with their g8 analyzer.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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