(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, an fse performed servicing and during evaluation found leaking at the column, which correlates with extra peaks.Fse replaced tubing from the column to the preheater, preheater filter and then reset the filter count.They adjusted the flow rate and the instrument was operational.There was no further action required by fse.The most probable cause of the reported event was due bad tubing from column to preheater.
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On (b)(6) 20107, a customer reported leaking at the prefilter with their g8 analyzer.Technical support sent out a new ferrule to the customer.When the customer installed the ferrule, the noticed that the column tubing was leaking.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting a1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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