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

Model Number G8

Device Problem Mechanical Problem (1384)

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

Event Date 12/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer's site to address the reported event.Fse verified error from the error log.Fse removed covers and thoroughly cleaned and lubricated y and z guide rails.Fse also removed needle and noted a slight bend and replaced the needle.Fse replaced the drvr2 board, inspected z motor electrical connection, reseated and tweaked sampler y alignment to center of patient sample tube.The customer is using new sample racks, fse ran over 90 patient samples and 7 diluted patient samples with no issue or errors.Instrument is operating as expected.Error reoccurred after several days, fse returned to customer's site to resolve issue.Fse verified from the printed error report that the 708 x1-axis error reoccurred.During evaluation, the fse found that error only occurs when the 10th sample in rack is introduced to upper rollers if sample tube is slightly lifted.Fse removed loader, cleaned and lubricated every guide rail, roller, pia sensor and belt for x1 and x2 movement.Fse replaced x1 motor, re-installed loader and performed alignments for x, y and z positions.Fse also ran sample loader (sl) rotate over 20times without any error, cleaned all rack bases that contact lower roller.Customer successfully ran quality control and 20 patient samples without errors and within acceptable ranges.No further action required by field service.The g8 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4).There were two (2) similar complaints identified during the searched period, which includes this event.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting states the following: 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.708 x1-axis error: an abnormality occurred in the operation error in the x1-axis.If this occurs, inspect the x1-axis.Then, execute sl rotate.The most probable cause of the reported event was due to faulty driver 2 board and x1 motor.

Event Description

A customer reported getting a 708 x1-axis error message on the g8 instrument.The customer stated error had previously occurred.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

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.H.3.Device evaluation by manufacturer: the driver 2 board was returned to tosoh instrument service center for investigation.Functional testing could not duplicate reported x1-axis error, but confirmed failure of board.Part will be discarded.The sample needle was returned to tosoh instrument service center for investigation.A visual inspection confirmed failed needle due to a bent tip.Part will be discarded.The most probable cause of the reported event was due to faulty driver 2 board and sampling needle.

• 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, japan 10586 23; JA 1058623
• MDR Report Key: 8280072
• MDR Text Key: 134587947
• Report Number: 8031673-2018-05437
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2019,04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2019
• Distributor Facility Aware Date: 12/28/2018
• Device Age: 8 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/25/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1