(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On 06-apr-2017, fse arrived at the site to address the reported event.Inspection of the device identified the issue with the tubing from the bottom of the prefilter assembly to the i-6 port on the injector valve.Fse replaced the tubing, stator, rotor seal, the 6-port stator, and the sample loop.No further issues were reported and no further action was required by field service.The most probable cause of the reported event was due to a fault/ failure of the peek tubing from the bottom of the prefilter assembly to port i-6 on the injector valve.
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On (b)(6) 2017, the customer reported "error 100", "102 high pressure" and "150 grad.Sensor" with their g8 analyzer.The customer further stated that they were unable to turn off the alarm.On (b)(6) 2017, 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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