On (b)(6) 2017, a field service engineer (fse) conducted on-site follow-up with the customer.The fse observed that the wash block for the needle was leaking.The fse replaced the wash block and ran a degasser and purge check to verify that the issue was resolved.The instrument was returned to normal operation.The most probable cause of the reported event was due to a defective needle wash block.(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) 2017, a customer reported fluctuating sa1c retention times with their g8 analyzer.The customer is unable to run hba1c patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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