(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, an fse conducted follow-up with the customer to address the reported event.During servicing, fse observed a leak at the sample loop and replaced it.The system was found to be clogged and the 1-6 tubing at the injection valve and tubing from the preheater to the prefilter were replaced.To evaluate if the issue had resolved, fse ran precision and quality control (qc) and all were in range.They also ran patient samples without any errors.The instrument was operational.There was no further action required by fse.The most probable cause of the reported event was due to a bad injection valve and loose sample loop.
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On (b)(6) 2017, a customer reported a leak at the peeking tubing connection with their g8 analyzer.The customer tightened the 6-way valve but it did not resolve the leak.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting a1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
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