(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On 31-oct-2016, fse arrived at the site to address the reported event.Upon inspection, fse noted over pressure occuring with the tubing exiting the column leading into the detector.The tubing was removed and back-flushed, which removed the flow blockage.Fse also found a loose ferrule in the head of the column.The leak was resolved by removing the loose ferrule.Next, the parts were reassembled and pressure, flow, and leak tests were performed.Finally, fse replaced the tubing assembly exiting the column outlet and entering the flow cell inlet.Twenty patient samples ran with normal results.No further issues were noted and the system was determined to be functioning properly.No further action was required by field service.The most probable cause of the reported event was due to fault/ failure of the peek tubing.
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On (b)(6) 2016, the customer reported a leak on the left side of the column with their g8 analyzer.The customer further stated that the raven could not be attached and the tubing "appeared to be pushed out by something on the end of the new column".On (b)(6) 2016, 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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