Device evaluation by manufacturer: a field service engineer (fse) followed-up with the customer over-the-phone and confirmed that the issue was resolved by replacing a bent sampling needle assembly.The customer ran quality controls and patient samples without any issues.The g8 instrument was performing according to manufacturer's specifications.No further action was required by the fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(4) 2017 through aware date (b)(4) 2018.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: 6.3 error messages when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages: with these errors, the assay stops and the analyzer immediately enters stand-by state.The 706 syringe-l error: explanation: operation error in syringe-l.Countermeasure: inspect x1-axis.Inspect syringe-l.Execute smp.Reset.Chapter 5, maintenance procedures, under section 5.10 provides step-by-step instructions on the sampling needle assembly replacement.The most probable cause of the reported 706 syringe-l error message was due to a bent sampling needle assembly.Additional manufacturer narrative: (b)(4).
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