(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On 10-may-2017, fse arrived at the site to address the reported event.Inspection of the device revealed the prefilter housing was leaking from the l-6 fitting.Fse replaced the prefilter, then removed, cleaned and reinstalled the housing.The customer verified quality control (qc) and the device was reported to be functioning properly.No further action was required by field service.The most probable cause of the reported event was due to a loose connection on the prefilter housing.
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On (b)(6) 2017, the customer reported a fluid leak that appeared to be coming from behind the filter assembly with their g8 analyzer.The customer reported that the manual pressure reading was -0.16 mega pascals (mpa) and the drain valve was closed.On (b)(4) 2017, 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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