(b)(4).On (b)(6) 2016, an fse visited the customer to address the reported event.During servicing, fse evaluated the instrument and found the 2 way valve for the reagent defective.Fse replaced the 2-way valve and ran several patient controls to check instrument operation.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event was a defective 2-way valve.
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On (b)(6) 2016, a customer low pressure for a few days with their g8 analyzer.The customer tried performing a dain flush and the pressure bottomed out in the middle of a run.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hga1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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