On (b)(6) 2016, an fse was dispatched to the customer site to address the reported event.The fse found evidence of leaking under the pump and check valves.The fse replaced the diaphram, both check valves plunger seals and large syringe tip, then ran calibrators, controls and patients without issues.The instrument is operational.The g8 analyzer was functioning as intended with all issues cleared.No further action required by the fse.The most probable cause of the reported event was due to leaky check valve seals.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).
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On (b)(6) 2016, a customer reported frequent flow rate modifications for drifting retention times with their g8 analyzer.The customer is unable to run hba1c patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in discrepant and 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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