(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, an fse visited the customer to address the reported event.During servicing, fse cut the tip of the peek tubing i-6 tubing and reinstalled it with a new ferrule to correct the high pressures.The instrument was run without any high pressure errors and was verified as operational.There was no further action required by fse.The most probable cause of the reported event was clogged i-6 tubing.
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On (b)(6) 2016, a customer reported high pressures after changing the columns and running calibration/quality control (qc) with their g8 analyzer.The customer reported that they changed the filter but the high pressure persisted.Technical support advised to remove the filter holder and check pressure without the filter, but the analyzer continued to alarm showing a blockage before the filter assembly.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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