On 26-may-2015, an field service engineer (fse) visited the customer to address the reported event.During servicing, fse could not duplicate the issue.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event could not be determined.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).
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On (b)(6) 2015, a customer reported varying pressures with their g8 analyzer.Technical support advised the customer to replace the filter.The customer then checked the pressures and reported that they were normal.However, when running patient samples, they report that the pressures would fluctuate between high and low.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hga1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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