(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, fse conducted follow-up with the customer over-the-phone to address the reported event.Fse performed troubleshooting with the customer to replace the peek tubing.Next, the customer was able to run quality control (qc) and patient samples with no issues.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) 2017, the customer reported that during a filter change for their g8 analyzer, the peek tubing snapped.On (b)(6) 2017, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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