(b)(4).Device evaluation by manufacturer: a field service engineer (fse) contacted the customer over-the-phone to address the reported event.Fse was able to troubleshoot the instrument so that the customer was able to run.Fse then went onsite to perform service.During servicing, fse was unable to duplicate the errors as the customer had already cleaned the sample needle guide rail to allow smooth z-movement during troubleshooting.Fse then recleaned and lubricated the guiderails.Fse removed the needle and found the tip slightly bent, straightened and ordered a replacement.Fse remove two rubber o-rings at the base of the needle and cleaned the area.Fse also adjusted x and y alignments for the sample loader to the center of the patient tube.Fse performed general cleaning of the analyzer and found no further issues or concerns.The customer noted that the drain bottle never needed to be emptied.Fse then cleaned the wash well and verified good flow of waste into waste bottle.The customer ran quality controls (qc) and several patient samples without any errors.The instrument was operating as expected.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 13-nov-2017 through aware date (b)(6) 2018.There were no similar complaints including this complaint 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.710 z1-axis error: an abnormality occurred in the up and down movement of the sampling needle.If this occurs during a stat assay, check that the container setting (cup or tube) is correctly set.The error also occurs when the sample vial was not recognized as a primary tube, due to the disoriented sample sensor.The most probable cause of the reported event was due to the x and y axis were out of alignment.
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