(b)(4).This report is being submitted due to a retrospective review conducted under (b)(4).On (b)(4) 2016, fse arrived at the site to address the reported event.Inspection of the device revealed air in the hemolysis wash and air in the system.Fse performed a drain flush, primed all four lines, and ran pressure & flow testing prior to running patient samples.The patient samples were normal after the intervention.No further action was required by field service.The most probable cause of the reported event was due to air in the fluidic system.
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On (b)(6) 2016, the customer reported getting low total area on all controls and patient samples with their g8 analyzer.The customer stated that he did not have a spare needle to exchange so he attempted to remove the same needle and flush it out.Troubleshooting did not resolve the issue.On (b)(4) 2016, a field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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