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

Model Number G8

Device Problems Decrease in Pressure (1490); Output Problem (3005)

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

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address the reported event.During the evaluation, fse verified the pressure as 6.4 mpa (the range of the new column is 6.7-10.7 mpa).Fse then replaced both check valves and ran several whole blood patient samples.The pressure was running at 8.2 mpa.Fse then adjusted the flow factor (ff) to 1.12 ml/min and the retention time was running at 0.59-0.60 minutes.Calibration was performed successfully and quality control (qc) results were acceptable.Upon follow-up, the customer reported high total areas.Fse returned to the site and replaced the injector valve.The total areas were in normal range (the optimum total area is 700 to 3000).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 (b)(4) from 10-jul-2017 through aware date (b)(6) 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.1.8 limitations of the procedure: total area: dilution studies demonstrate that the assay is linear from a total area of 500 to 4000.However, the optimum total area is 700 to 3000.Interpretation of results: results will not be reported if the total area (ta) is <500 which can be seen in severe anemia.Results will not be reported if the ta is >4000 which can be seen in polycythemia.(see "abnormal red cell survival in previous section).The optimal goal for total area is between 700-3000.However a ta in the range of 500-4000 is acceptable and reportable for whole blood specimens.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 reported events was due to bad check valves and a bad injector valve.

Event Description

A customer reported that after putting on a new column, they were getting low pressures on the g8 instrument.They tried running patient samples and the sa1c retention time (rt) was 0.56 minutes.The customer reported that the flow factor (ff) was 1.01 ml/min.They tried calibrating, but the calibration failed.Technical support (ts) instructed the customer to reduce the ff to 1.00 ml/min, power the instrument on and off, and then run patient samples to check the sa1c retention time (rt).However, the sa1c rt was still 0.57 minutes and 0.58 minutes.Ts then instructed the customer to further reduce the ff to 0.98 ml/min.The sa1c rt stayed at 0.58 minutes but all of the samples had produced hemoglobin variant flags of p-hv3 and p01.The customer sent the chromatograms to ts for further evaluation and the p-hv3 and p01 flags were confirmed.Field service engineering 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

(b)(4), per exemption number e2017013.

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 valve, purge check valve, and rheodyne valve were returned for evaluation.Functional testing was performed on the uptake and purge check valves by testing whole blood.The retention time was unstable and running fast.The error was duplicated.The uptake and purge check valves failed testing.The rheodyne valve was visually inspected and found the factory alignment on back of the valve was moved.The factory adjustment when moved renders the part as damaged.The part failed visual inspection.The reported issue was confirmed.

• 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: 7801230
• MDR Text Key: 118096491
• Report Number: 8031673-2018-00794
• 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,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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: 08/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2018
• Distributor Facility Aware Date: 11/30/2018
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/06/2018
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1