(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, an fse conducted a service call to address the reported event.Fse evaluated the issue and determined the issue to be related to the line filter tubing.Fse ordered the replacement tubing for the customer to self-install.After installation, customer did not report any further events related to low pressure or leaks.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event was preheater to filter tubing.
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On (b)(6) 2016, a customer reported low pressures with their g8 analyzer.The customer noticed a leak around the filter and replaced the filter.However, the instrument was still having leakage.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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