(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.Fse replaced the large syringe and tightened the allen screws on the injector valve assembly due to the identification of a small leak.Then, he ran qc and twenty patient samples with good results and no evidence of leaks.No further action was required by field service.The most probable cause of the reported event was due to a worn large syringe tip.
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On (b)(6) 2016, the customer reported low total areas using manual dilution with their g8 analyzer.Technical support (ts) reviewed the customer's quality control (qc) practices and asked them to send tosoh qc for evaluation.The customer was concerned that the issue was related to a mechanical issue with the device.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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