(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On 19-apr-2017, fse arrived at the site to address the reported event.Fse replaced the tube from the injection valve to the line filter.Next, they ran, calibration, controls, and verified pressure was under 9.0 mega pascals (mpa).No further action was required by field service.The most probable cause of the reported event was fault/ failure of the peek tubing.
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On (b)(6) 2017, the customer reported sporadic high pressure with their g8 analyzer.The customer stated that they had already changed the filter with no resolution.Technical support (ts) asked the customer to verify the buffer filters had been changed.They confirmed that five filters had been used in a ten day period.On (b)(6) 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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