(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).On (b)(4) 2017, fse conducted follow-up with the customer over-the-phone to address the reported event.Fse performed troubleshooting with the customer to verify the location of the leak.Next, the customer was instructed to disassemble the fitting, clean the build up from the buffer, then reassemble.There were subsequently no further reports of leaks.No further action was required by field service.The most probable cause of the reported event was due to a loose fitting of the internal tubing.
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On (b)(6) 2017, the customer reported leaking at the fitting from the preheater to the column input with their g8 analyzer.On (b)(4) 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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