(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).On (b)(6) 2016, fse arrived at the site to address the reported event.Upon arrival, fse ran patient samples, which returned with good results; however, the second sample had no color in the dilution well.Fse subsequently replaced both the syringe tip, the sample needle, the seals in both valves, and the small syringe.The device was recalibrated and qc and patient samples ran with no further issue.On (b)(6) 2016, fse followed up with the customer again.The customer reported that they were still getting some high total areas.They cleaned the ports on both valves again and replaced the solution.About 60 patient samples ran, and results came back with poo peaks.The customer replaced both check valves.Patient samples and quality control (qc) subsequently ran with no further issues.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 total area on both hemolysates and whole blood with their g8 analyzer.The customer stated that the wash diluent was changed, there no air bubbles in the tubing, and no overflow from the wash/diluent wells.Later, the customer called technical support (ts) back to report that the sample needle was misaligned.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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