(b)(4).On (b)(6) 2016, fse conducted follow-up with the customer over-the-phone to address the reported event.Fse performed troubleshooting with the customer to guide her in replacing a second, used needle.There were no further reports of issues post-intervention.No further action was required by field service.The most probable cause of the reported event due to an occluded needle.
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On (b)(6) 2016, the customer reported "error 706 l syringe" with their g8 analyzer.Technical support (ts) advised the customer to change out the sample needle, but the error persisted.Next, the customer was instructed to clean the coil under the syringes and repower.The error repeated itself, and was now accompanied by a noise.On (b)(6) 2016 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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