(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, an fse visited the customer to address the reported event.During servicing, fse found the instrument leaking around the t-handle and the nut on the line filter.They also found that the ferrule was not staying on the peek tubing.Fse then replaced the tube for the line filter.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event was the tube for the line filter.
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On (b)(6) 2017, a customer reported that a leak is occurring at the top of the filter housing where the outlet peek tubing attaches on their g8 analyzer.The customer stated that the leak occurred after they performed a prefilter replacement.Technical support tried troubleshooting with the customer in tightening the peek fitting but the leaking continued.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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