(b)(4).A field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse replaced the damaged waste tube and aligned the loader.The fse confirmed that the waste tube was cut short.The patient sample was not used to validate the repair.The damaged waste tubing was contaminated and disposed of at the customer site.All errors cleared and the g8 instrument was operational.No further actions were required by field service.A 13-month complaint / service history review for similar complaints was performed for the serial number (b)(4) from aware date of (b)(4) 2018, which included data from 28 may 2017 through (b)(4) 2018.There were no similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 6 troubleshooting is as follows: 200 area low error.Three successive results below the lower limit of the total area (50) occur.If the error message is present when sufficient volume of sample is set in the rack, the problem may be caused by an empty reagent (hemolysis & wash solution).Check the remaining volume of hemolysis & wash solution and start the assay again.The most probable cause for the reported event was the waste tank needed to be moved.
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