(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On (b)(4) 2016, fse arrived at the site to address the reported issue.Fse lubricated the syringes and needle rod, and tightened the p6 and injector valve screws.Then, calibration and controls were run to verify the device was functioning properly.No further action was required by field service.The most probable cause of the reported event was due to fault/failure of the small syringe.
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On (b)(6) 2016, the customer reported low pressure and low total area on capped, whole blood samples with their g8 analyzer.Preventative maintenance was performed earlier that week and a new sample needle installed.The customer performed a single drain flush.Technical support (ts) asked her to confirm all the reagents and to perform another drain flush.On (b)(6) 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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