(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On 01-dec-2016, fse arrived at the site to address the reported event.Inspection of the device found that high pressure from a loose ferrule on the sample loop caused a low pressure alarm.Fse replaced the sample loop, i-6 tubing from the injection valve to the bottom of the prefilter assembly, and performed a drain flush.The device ran through the entire warm up cycle with pressure remaining steady at 9.4 mega pascals (mpa), and no leaks.Quality control (qc) run was also within range.No further action was required by field service.The most probable cause of the reported event was due to fault/ failure of injection valve.
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On (b)(6) 2016, the customer reported low pressure and leaking from the injection valve on the left side of their g8 analyzer.On (b)(6) 2016 field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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