(b)(4).Device evaluation by manufacturer: field service engineer (fse) visited the customer to address the reported event.During evaluation, the fse was able to confirm the z1-axis errors on print out.Fse checked all alignments to sample.Fse lubricated z and y axis with triflow.Fse installed a new sample needle and checked to make sure needle was not hitting inside of lucite block.Fse ran controls, precision, and 2 racks of patients.The instrument was verified as operational.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints found during this time.The g8 operator's manual under chapter 5 maintenance procedures, 5.10 sampling needle replacement has a caution that states the following: replace the sampling needle if it is bent or broken.Use the following procedure to replace the sampling needle.Access to the inside of the analyzer is needed to replace the sampling needle.Be sure that only personnel who have been trained by tosoh or its representatives perform these operations.Be sure to wear protective clothing (goggles, gloves, mask, etc.) and take sufficient care to prevent infection during handling.Take care not to touch the end of the sampling needle during handling.If the needle placement is clearly off center of the primary tube, it must be adjusted.Cancel the assay and contact technical support.The most probable cause of the bent sample needle was due to lack of lubrication of the y-axis.
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