A field service engineer was dispatched on (b)(6) 2016.The fse replaced the pump plunger, diaphragm and plunger seal.No further action required by field service.The g7 analyzer was functioning as intended with all issues cleared.The most probable cause of the reported event was pump unit, failure of plunger seal.This report is being submitted due to a retrospective review conducted under capa(b)(4).
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On (b)(6) 2016 a customer reported a noise near pump (clicking) with their g7 analyzer.The technical support specialist (tss) assisted the customer in troubleshooting by instructing to clean beneath the large and small syringes, however, this did not resolve the issue.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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