On (b)(6) 2016, the technical service specialist provided troubleshooting with the customer over-the-phone to address the reported event.The tss determined that the customer last calibrated the instrument nearly 4 weeks ago.The tss recommended the customer recalibrate which resolved the issue.The ala -360 analyzer is functioning as intended with all issues cleared.No further action required.The most probable cause of the reported event was due to the calibration was near expiration.(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).
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On (b)(6) 2016, a customer reported patient and controls are high with the aia-360 analyzer.The customer is unable to run hba1c patient samples.A technical service specialist assisted the customer to address the reported event, which resulted in discrepant patient results and 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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