(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse replaced the sample needle and allowed the g8 to go through its start up cycle.The fse ran several racks of patient samples, all chromatograms good, no leaks, no syringe errors.All errors cleared and the g8 instrument is operational.No further action is required by field service.The most probable cause for error 706 syringe-l was the ben and clogged needle.
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On (b)(6) 2017, a customer reported error 706 syringe-l error with the g8 analyzer.The customer cleaned the large syringe but the error persisted.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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