(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse replaced both check valves, adjusted the flow rate from 1.19 down to 1.05.The retention time was in acceptable range.All errors cleared and the g8 instrument is operational.No further action is required by field service.The most probable cause of the reported event was both check valves needed to be replaced.
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On (b)(6) 2016, a customer reported there were long retention times with the new column with the g8 analyzer.The customer adjusted the flow factor, rebooted the analyzer, and recalibrated 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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