(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) 2017, fse conducted follow-up with the customer over-the-phone to address the reported event.Fse performed troubleshooting with the customer to flush out the line.The customer was subsequently able to run patient samples without any further issues.No further action was required by field service.The most probable cause of the reported event was due to a clot in the internal tubing.
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On (b)(6) 2017, the customer reported low total area with their g8 analyzer.Technical support (ts) instructed the customer to replace the sample needle.There were no reports of waste backing up.On (b)(6) 2017, 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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