(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, fse arrived at the site to address the reported event.Fse lubricated the large syringe lead screw and guide rod.Next, he placed the device in the pump clean cycle and ran several patient samples.There were no further issues reported.No further action was required by field service.The most probable cause of the reported event was due to fault/ failure of the large syringe.
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On (b)(6) 2016, the customer reported receiving an intermittent squeal/squeak during the pump clean cycle with their g8 analyzer.The customer stated that they had recently replaced the large syringe.On (b)(6) 2016 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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