(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).On (b)(6) 2017, fse arrived at the site to address the reported event.Fse replaced the tube for the line filter.The customer monitored the correct installation of the tube and positioning of the prefilter housing connections.Next, they ran controls, verified results, and correct operation.No further action was required by field service.The most probable cause of the reported event was due to a worn tube for the line filter.
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On (b)(6) 2017, the customer reported that the tubing connector had broken and was stuck inside the metal filter holder/ connector with their g8 analyzer.Technical support (ts) sent replacement tubing to the site; however, the issue did not resolve.On (b)(6) 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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