On (b)(4) 2016, an fse was dispatched to the customer site to address the reported event.The fse replaced and aligned the test cup pick-up assembly, verified all cup transfer alignments and adjusted the clot detection and inspected the sample nozzle.The fse also verified all alignments due to the intermittent clot detection on the pretreatment and ran daily maintenance.The customer ran qc with no errors.The aia-900 analyzer was functioning as intended with all errors cleared.No further action required by the fse.The most probable cause of the reported event was due the cup chuck motor.(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, a customer reported experiencing intermittent 2163 (c trans home overrun) errors with the aia-900 analyzer.The customer is unable to run pth patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting pth patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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