(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, an fse visited the customer to address the reported event.During servicing, fse checked the tubing and the dilution well.Fse found that the waste well was clogged and cleaned and de-clogged appropriately.Fse then ran patient samples without any issues.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event was a clogged dilution waste well.
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On (b)(6) 2016, a customer reported low total areas and a leak from the back of their g8 analyzer.The customer reports that they observe leaking from the back but no liquid in the pan or in the waste tubing.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hga1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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