(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2015, fse arrived at the site to address the reported event.Fse replaced the 6-way & rotary valves, the inlet & outlet check valves, and the small syringe.He verified that the device was functioning properly by running quality control (qc), and several patient samples to confirm good total area.No further errors were detected.Additional follow-up by fse the next day verified that the device was still functioning properly.No futher action was required by field service.The most probable cause of the reported event was due to failure of the small syringe.
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On (b)(6) 2015, the customer called to report persistant low total areas with their g8 analyzer.On (b)(6) 2015, 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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