(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On 19-apr-2016, fse arrived at the site to address the reported event.Fse replaced the small syringe, flushed the p6 tube, replaced the filter and the column.Then, he reset the counters for the filter and columns.The customer was subsequently able to run patient samples without issue.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 with their g8 analyzer.On (b)(4) 2016, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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