A field service engineer (fse) was dispersed who replaced the peek tubing from the injector valve i-6 to the line filter.Fse ran qc and customer samples, but the results were on the low side.The sample syringe tip was subsequently replaced.Fse reran the patient samples, calibrated, and reran qc with no further errors.No further action was required by field service.The probable cause of the reported event was due to fault/ failure of the peek tubing from i-6 to the line filter.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).
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On (b)(6) 2016, the customer reported high pressure with their g8 analyzer.A field service engineer (fse) was dispatched on (b)(6) 2016, to address the reported event,which resulted in delay in reporting of patient results hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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