(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.Fse replaced the small syringe, then calibrated and ran quality control (qc).Next, he ran patient samples.Two results returned with high total area.Fse removed the tube caps and reran the samples.The total areas returned with good results on the second run.Next, he ran several racks of patients and no issues with missing peaks were noted.No further action was required by field service.The most probable cause of the reported event was due to fault/ failure of a column.
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On (b)(6) 2016, the customer reported missing peaks and high total area with their g8 analyzer.On (b)(6) 2016 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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