(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 made a new connection for top of the filter housing.Next, he primed the device and pressures returned to normal.The customer was able to run quality control (qc) 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 peek tubing and ferrule.
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On (b)(6) 2016, the customer reported having issues after replacing the prefilter for their g8 analyzer.The customer stated that during tigthening of the black outlet peek tubing fitting, the threads stripped and now the black fitting no longer tightens.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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