MAUDE Adverse Event Report: TOSOH CORPORATION TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived at the site to address the reported event.Fse was unable to duplicate the issue while on site; but, confirmed the "710 z-axis" errors via the error log.Fse cleaned and lubricated the spiral lead screw, and checked and cleaned the top sensors for z movement of the pipettor.Fse also ordered new sample racks and sample rack adapter ring for the customer.The customer was instructed to install the parts upon receipt to see if this resolved the issue.No further information was provided.A 13 month complaint history review and service history review for similar complaints was performed for the serial (b)(4) from 18apr2017 through aware date (b)(6) 2018.There were two similar complaints identified during the search 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.Chapter 5, maintenance procedures, under section 5.10 provides step-by-step instructions on the sampling needle assembly replacement.The most probable cause of the reported event remains unknown as the investigation is ongoing.

Event Description

It was reported that the customer experienced ongoing "710 z-axis" errors with their g8 analyzer.The customer attempted to troubleshoot by changing the sampling needle assembly, cleaning the shaft and screw drive, and lubricating them with tri-flow.The issue resolved initially; however, returned again with increased frequency; now occurring every five to seven samples.Three days later, the customer called back to report continued "710 z-axis" error.The customer stated that the field service engineer (fse) sent tri-flow to apply to the sampling needle assembly guide rod.The customer stated that after application with tri-flow the errors stopped briefly, but returned again.Two days later, the customer called back to report experiencing the same errors despite receiving service.Fse was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Results code(s): 4315: no findings available conclusion code(s): 4315: cause not established.Additional information received by fse indicates that the device will not be retuned for evaluation.Additionally, the customer contacted ts on 08jun2018 to report receiving the same error message.This event was captured under mfr report# 3005529799-2018-00596; uf/importer report #: 8031673-2018-00596.No further information has been provided.The most probable cause of the reported event remains unknown.Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba- koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 7563627
• MDR Text Key: 110197783
• Report Number: 8031673-2018-00513
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G8
• Device Catalogue Number: 021560
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2018
• Distributor Facility Aware Date: 06/21/2018
• Device Age: 8 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/22/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1