(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, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse spoke to the customer over the phone, ordered a sample needle, and instructed the customer on how to install the sample needle.All errors cleared and the g8 instrument is operational.No further action is required by field service.The most probable cause for the reported event was the bent sample needle.
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On (b)(6) 2016, a customer reported a bent sample needle on the g8 instrument.The customer was receiving error 709 y1 axis and found the bent sample needle as a result of inspecting the unit due to the error.The customer is unable to run patient samples on hba1c diabetes assay.On (b)(6) 2016, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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