(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, an fse conducted follow-up with the customer over-the-phone to address the reported event.Fse performed troubleshooting with the customer and had the customer try running qc in stat position and the same errors occured.The fse ordered the customer a replacement needle and had them replace their needle.The customer then ran calibrations, and the qc and patient samples had no errors.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event was due to an occluded sample needle.
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On (b)(6) 2016, a customer reported sample sensor issues with their g8 analyzer.They tried remaking the controls and moving the controls deeper into the rack but the issue persisted.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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