(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 removed and replaced the broken ferrule on top of the prefilter assembly to correct issue.No further issues were reported.No further action was required by field service.The most probable cause of the reported event was due to a broken ferrule on the prefilter assembly.
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On (b)(6) 2016, the customer reported that she was unable to change the filter due to the inability of the tubing to be removed from their g8 analyzer.The customer further stated that the screw thread had been stripped.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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