(b)(4).On (b)(6) 2017, fse arrived at the site to address the reported event.Inspection of the device revealed that the damper tubing fittings were loose.Fse replaced the damper tubing assembly with new fittings.Next, he verified controls and that the device was functioning properly.No further issues were noted.No further action was required by field service.The most probable cause of the reported event was due to fault/ failure of the damper tubing and fitting.
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On (b)(6) 2017, the customer reported low pressure with their g8 analyzer.On (b)(6) 2017, 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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