(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, fse arrived at the site to address the reported event.Inspection of the device revealed that the #6 line was clogged.The line was replaced, and tested with no further errors.The customer was able to run calibration and quality control (qc) with issue.No further action was required by field service.The most probable cause of the reported event was due to clogged #6 line.
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On (b)(6) 2017, the customer reported a high pressure alarm with their g8 analyzer.Technical support (ts) suggested the customer changed the filter, but the pressure remained high.Next, the filter was removed.Pressure remained high at greater than 15 mega pascals (mpa).On (b)(6) 2017 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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