(b)(4).A field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse replaced the asm board.The system then displayed x1 errors because the asm board was bad.The fse replaced the drv2 board.The fse tested the system and ran quality control (qc).All results were within acceptable range.All errors cleared and the g8 instrument is operational.No further action is required by field service.The parts for the driver#2 pc board and the asm pc board were returned to tosoh and were evaluated.The driver # 2 pc board was installed into a refurbished g8 testbed.The technician activated the sample head to allow the sample head to travel on the y-axis rail and the z-axis rail.Although the sample head should be able to travel on the y-axis and utilize the z-axis when commanded to, the y-axis stalled and would not move down the rail.This error was duplicated.The hybrid power module on the driver card for the y-axis was not functional.This part failed.The asm pc board was installed on the g8 refurbished testbed to activate the instrument.The asm board failed to load when the technician attempted to download the software.The asm board was non-functional.There was an internal problem with this board.This part failed.Both parts were disposed.A 13-month complaint / service history review for similar complaints was performed for the serial (b)(4) from aware date of (b)(6) 2018, which included data from 6 may 2017 through (b)(6) 2018.There were two similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 6 troubleshooting as follows: error message: 709 y1-axis error.Explanation: operation error in y1-axis.Countermeasure: inspect y1-axis.Execute smp.Reset.The most probable cause for the reported event was the failure of the drv2 and asm pc board.
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A customer reported that during a run on the g8 instrument, the sample assembly did not move forward enough to position the sample needle correctly over the tube.The sample assembly made a grunting noise and started to move, then stopped.The racks moved normally.The customer also reported a 709 y1-axis error and the sample needle was bent.The customer is unable to run patient samples on hba1c.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
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