(b)(4).Device evaluation by manufacturer: on 13-mar-2018, a field service engineer (fse) was dispatched to the customer's facility to address the reported event.Fse cleaned and lubricated the sample probe rod and screw.Customer also mentioned had to increase the flow rate to 1.1.Fse performed troubleshooting and found the pump was leaking.Fse replaced the pump, adjusted the instrument's flow rate to 1.04, and primed the instrument.Fse then ran precision and quality controls (qc); all results were within acceptable range.The g8 instrument is functioning as intended and the reported error cleared.No further action required from field service.A 13-month complaint history review and service history review for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018 for similar complaints was performed.There was one (1) other similar complaint identified during the searched period.The g8 operator's manual under chapter 6: troubleshooting, message 710 z1-axis error.This error message is generated when there is operation error in z1-axis, i.E.An abnormality occurred in the up and down movement of the sampling needle.The error also occurs when the sample vial was not recognized as a primary tube, due to the disoriented sample sensor.The countermeasure is for the customer is to inspect z1-axis.Execute smp.Reset.Also, if this occurs during a stat assay, check that the container setting (cup or tube) is correctly set.The most probable cause of the reported event was due to leaking pump.
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On (b)(6) 2018, customer reported getting message 710 z1-axis error on the g8 instrument.Customer stated the sample needle was changed but the error persisted.Technical support specialist (tss) had the customer run one rack of samples with caps removed; the error cleared.Customer reported will continue to run the instrument without the caps, but requested onsite service.On 13-mar-2018, field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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