(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).On (b)(6) 2016, fse arrived at the site to address the reported event.Inspection of the device revealed that the large syringe set screw had become loose.Fse tightened the screw, then ran calibration, quality control (qc), and precision check without issue.The customer was subsequently able to resume operation.No further action was required by field service.The most probable cause of the reported event was due to a loose set screw of the large syringe.
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On (b)(6) 2016, the customer reported low total area on most whole blood samples with their g8 analyzer.Total areas were on the low side the day prior as well.The customer reported that he had already replaced the hemolysis wash (h/w), and sample needle, and verified that the waste line was flowing freely.He further reported that he would attempt to run some patient samples with the caps off.On (b)(6) 2016, 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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