(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).Fse was dispatched and on (b)(4) 2017 replaced 2 way solenoid valve and column det kit.Replaced buffers #1 & #3 and hem-wash solution.Cleaned lubed syringe motors and y-axis rails.Replaced buffer bag filters from customer stock.Replaced prefilter column, reset counts for both.Ran precision without errors.Ran calibration and qc, passed.Ran several patient samples all passed.The most probable cause of the reported event was failure of 2 way solenoid valve and column.
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On (b)(6) 2017 the customer reported getting p00 peaks on both qc (quality control) and patient samples with their hlc-723g8 analyzer.Checked system for leaks and none found, bled system of air.Probable check valve or pump related issue.On (b)(6) 2017 customer called to ask about the fse arrival time because the analyzer is not working.The customer is unable to run hba1c patient samples.A 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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