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 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the reported event.During servicing, fse confirmed the issue by running several patient samples.Fse replaced the purge and uptake valves, and adjusted the flow factor from 1.38 ml/min to 1.10 ml/min.Fse then performed quality controls with acceptable results and the retention time was 0.59 minutes.Fse ran several full racks of patient samples and the retention time was stable at 0.58-0.59 minutes.The instrument was operating as expected.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 26-oct-2017 through aware date 26-nov-2018.There were no similar complaints found during the searched period.The g8 operator's manual under chapter 1, introduction and applications, states the following: the time from injection of the sample to the time the specific peak elutes off the column is called retention time.The tosoh automated glycohemoglobin analyzer hlc-723g8 software has been written so that each of the expected fractions has a window of acceptable retention times.If the designated peak falls within the expected window, the chromatogram peaks will be properly identified.When a peak elutes at a retention time not within a specified window, an unknown peak (p00) results.If more than one peak elutes at times not specified by the software windows, each is given a sequential p0x title.In order to keep the peaks within their appropriate windows, it may be necessary to change how fast or slow the buffers are moving through the system by changing the pump flow rate.When there is a question concerning the chromatography, repeat the sample.If the repeated sample also displays unusual characteristics, it is appropriate to evaluate whether the unusual result is due to an abnormal sample, a procedural error, an instrument malfunction or a sample-handling problem.For further information, see the troubleshooting section in this operator's manual the g8 variant analysis mode training manual under lesson 8 - troubleshooting, states the following: adjusting the flow rate - how and why on the tosoh automated glycohemoglobin analyzer hlc-723g8; variant analysis mode it may be necessary to adjust the flow rate because either unidentifiable peaks appear on all the chromatograms or the average retention time for various peaks has changed significantly.The flow rate is changed by changing the flow factor in the instrument.The flow factor is generally 1.00 ml/min.The flow factor should only be adjusted +/- 0.05 of the default factory setting.The most probable cause of the reported issue was has not yet been determined.The investigation is in progress.

Event Description

A customer reported erratic retention times (rt) between 0.53-0.69 minutes on the g8 instrument.The column count was at 1022 injections.The customer stated that they flip the column at 800 injections and run the instrument until the 2500 injection warranty.They noticed the retention time problem after they flipped the column the week before.Technical support (ts) advised the customer that the column should not be flipped and should only be allowed for 2500 injections.Ts instructed the customer to change the column and run whole blood samples to check the retention time.The retention times were as follows: retention times : 1.0.69 minutes, 2.0.53 minutes, 3.0.00 minutes, 4.0.68 minutes, 5.0.68 minutes, 6.0.58 minutes, 7.0.00 minutes, 8.0.00 minutes.No patient results were reported since the problem had started.The instrument was down.Field service engineering (fse) was dispatched to address the reported, which resulted in delay of reporting hga1c patient results.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.Device evaluation by manufacturer: the uptake and purge check valves were returned for evaluation.Functional testing was performed on both check valves by initially running a drain flush to return the pressure to normal and then performing a precision testing to replicate retention time issues.All results were in range with both check valves.The issue could not be duplicated.The parts passed testing.Evaluation codes: method: 4109-historical data analysis, 10-testing of actual/suspected device, results: 213-no device problem found, conclusion code: 4315- cause not established.The most probable cause of the reported event could not be determined.The uptake and purge check valves performed as intended.

• 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: 8177363
• MDR Text Key: 131801601
• Report Number: 8031673-2018-05336
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Distributor Facility Aware Date: 01/22/2019
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/12/2019
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1