On (b)(6) 2016,an fse was dispatched to the customer site to address the reported event.The fse discovered the cup transfer assembly was causing intermittent cup transfer jams.The fse cleaned and lubricated the cup transfer assembly and performed all cup transfer alignments.The transfer intermittent z axis jams continued.The fse replaced the assembly and performed all cup transfer alignments and also replaced the d lane and performed all d lane alignments.The fse ran cup transfer macro 30 times with no errors detected.The customer ran qc and ran several patient samples with no errors detected and all passed.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 to d lane mis-position errors causing intermittent alignment problems.(b)(4) is submitting on behalf of the foreign manufacturer tosoh corporation, per exemption number (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 a 2160 error with the aia-900 analyzer.The customer reports c-trans not detect cup error and has repowered and restarted without success.The customer is unable to run fsh and prl patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting fsh and prl patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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