(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, fse arrived at the site to address the reported event.Inspection of the device revealed a loose ferrule nut near the column, which likely caused leaking and low pressure errors.Fse dried the column oven and retightened the ferrule.Fse subsequently ran controls and provided education to the customer.No further action was required by field service.The most probable cause of the reported event was due to a loose column ferrule nut.
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On (b)(6) 2017, the customer reported low pressure with their g8 analyzer.Technical support (ts) instructed the customer to perform a drain flush and replace reagent #1, but the error persisted.The customer denied seeing any obvious leaks.On (b)(6) 2017 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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