(b)(4).Fse arrived onsite to address the reported event.Fse located the tubing that had been displaced and rerouted it to the column; then verified the tubing was appropriately attached to ensure the issue did not recur.The customer ran four patient samples to verify the instrument was functioning correctly.No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 07jul2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 operator's manual under chapter 2- connections, was reviewed.The g8 operator's manual indicates that: 2.6 column connection.The dedicated column for the tosoh automated glycohemoglobin analyzer hlc-723g8 is the tskgel g8 variant hsi.Never use the g8 column with any other instrument.Be sure to check for any damage to the package or packaging components before use.If any damage is observed, contact your local representative.Next, confirm that the following inserts are included with the column.· instructions for use 1.· inspection report 1.Chapter 2, column connection, under section 2.6 provides step-by-step instructions on the column connection procedure.The most probable cause of the reported event was due to disconnection & retraction of the column tubing.
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