(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.Inspection of the device identified damage of the ptfe tubing from the pump to position four on the 6-way valve.Fse replaced the tubing, ferrules and bushings.No further leaks were reported.No further action was required by field service.The most probable cause of the reported event was due to fault/failure of internal tubing (ptfe tubing).
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On (b)(6) 2016, the customer reported the polytetrafluoroethylene (ptfe) tubing with their g8 analyzer was leaking.On (b)(6) 2016, 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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