(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On 12-aug-2016, fse arrived at the site to address the reported event.Fse changed the filter and replaced all the buffers and wash.Next, he ran whole blood and performed calibration and quality control (qc) with no errors.No further action was required by field service.The most probable cause of the reported event was due to operator error.
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On (b)(6) 2016, the customer reported that the sample rack advanced to the second position while calibrating their g8 analyzer.The analyzer had been installed on (b)(6) 2016.Technical sport (t) reviewed the calibration procedure with the customer; however, the issue persisted.On (b)(6) 2016, field service engineer (fse) was dispatched to address the reported event, which may have resulted in delayed reporting of hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the potential delay in reporting.
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