(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, a fse conducted follow-up with the customer over-the-phone to address the reported event.Fse performed troubleshooting with the customer and found that the customer was missing the ferrule for the i-6 line.Fse ordered a replacement i-6 line and when the customer received it, fse walked them through replacing it.After replacement, the customer was advised to perform a drain flush and run the pump.Thereafter, the customer reported normal pump pressues and the leaking had resolved.The instrument was verified to be operational.There was no further action by field service.The most probable cause of the reported event was due to damaged ferrule.
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On (b)(6) 2017, a customer reported that they are having a leak at the bottom of the pre-filter assembly with their g8 analyzer.The customer tried to resolve the leak by trimming back the peek tube beyond the compression marks but the leak persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting a1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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