(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, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse replaced the sample needle, injection seal, and stator face.The fse also adjusted the syringe uptake for better sample color in the dilution well.The fse ran samples.All results were within acceptable range.All errors cleared and the g8 instrument is operational.No further action is required by field service.The most probable cause for low total area and no peaks was the sample needle needed to be changed.
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On (b)(6) 2017, a customer reported a low total area and no peaks were detected with the g8 analyzer.The customer is unable to run hba1c patient samples.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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