(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On 29-nov-2016, fse arrived at the site to address the reported event.Inspection of the device revealed that the fittings for l-6 were "not snug enough", possibly allowing air into the system.Fse tightened the fittings and ran thirty patient samples.All returned with results within normal ranges.The customer was subsequently able to run patient samples without issue.No further action was required by field service.The most probable cause of the reported event was due to loosened l-6 tubing at the injection valve.
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On (b)(6) 2016, the customer reported receiving high total areas with their g8 analyzer.On (b)(4) 2016, 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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