(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).Fse followed up with the customer via telephone to address the reported event.Inspection of the device by the customer revealed that there was another machine on top of the waste tube impeding the waste flow.The customer adjusted the waste tube so that there were no restrictions and the waste started to flow again.Next, the customer ran quality control (qc) and four patient samples successfully, and with no leaking.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 (b)(6)2017 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, states the following: 2.5 connections: waste tube insert the waste tube firmly into the waste port located on the bottom of the main unit.(refer to fig.2-5) securely tighten the waste tube with the bandage provided in the accessory box.Insert the other end of the tube to the waste bottle.(refer to fig.2-6) note if the waste tube is bent, the waste eluent may not drain out smoothly.Adjust (cut) the tube length to keep the tube end above the waste eluent level.When changing the analyzer location, make sure that the tube is not loose, broken or bent and that the waste eluent drains out smoothly.The sample loader must also be temporarily disconnected when changing the analyzer location.If the waste tube is bent and waste eluent cannot smoothly drain, the sample dilution may not be accurately executed during the assay.Do not try to pick up or move the tube.Keep the waste tube end above the top of the waste eluent.The most probable cause of the reported event is due to operator error.
|