(b)(4).On (b)(6) 2016, an fse visited the customer to address the reported event.During servicing, fse inspected the unit and found an occlusion from port 6 of the injection valve to the filter housing.Fse replaced it with x-part.Fse ran controls with acceptable results.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event was an occlusion from port 6 to filter housing.
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On (b)(6) 2016, a customer reported high pressure errors with their g8 analyzer.The customer tried changing the filter with no changes.Technical support advised the customer to reboot the analyzer but the pressures remained high and analyzer was in standby.The analyzer rebooted without errors but it did not perform the standard warmup.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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