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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department for further investigation.The fse changed both check valves for pump unit and adjusted flow rate back to 1.12 ml/min.The fse tested the instrument with quality controls and patient samples where the retention time was between 0.58-0.61 minutes.On (b)(6) 2018 the customer reported receiving the error again.The fse found the pressure is unstable on the instrument.The fse replaced the pump unit but could not get any flow from the new pump.Fse found the buffer was not passing thru the purge check valve which led to the replacement of the plunger seal.This did not affect the change in pressure and error still persisted.Then the fse found the tubing from the 5 way manifold to the inlet check valve plugged.Fse cleared plug and replaced the ferrule on tubing.The pressure reading now is 8.67 mpa and the retention time is 0.59 minutes.A calibration and quality control run was performed by the fse and all results were within specifications without any errors.The instrument is functioning as intended and was released.No further actions are required by the fse.A complaint history review and service history review for similar complaints was performed for serial (b)(4) from the 30th of april 2017 through awareness date on (b)(6) 2018.There were no similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 1, introduction and applications, states the following: interpretation of results.The sa1c measuring range is 4.0 - 16.9%.The ideal retention time for sa1c is 0.59 minutes.The ideal retention time for a0 is 0.90 minutes.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 chromatogram must be examined for any unidentifiable peaks (i.E., p00, p01,) before the a0 peak.Do not report the result if these peaks exist.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 most probable cause of the reported issue was due to faulty purge and inlet check valves and a plugged tubing from 5 way manifold to inlet check valve.(b)(4).

Event Description

The customer reported that after changing column the retention times are high on patient samples.Customer indicated that the flow rate was adjusted from 1.10 ml/min to 1.13 ml/min.The technical support specialist (tss) had the customer adjust the flow rate to 1.15 ml/min and turn the analyzer off after adjustment.The customer then ran 5 whole blood samples to check retention time.Despite multiple adjustments to the flow rate they are still experiencing retention time of 0.62 minutes.Customer indicated the retention time flag is set high on the instrument and its flagging retention time of 0.61 minutes.On (b)(6) 2018 the customer called back reporting hba1c retention time 0.61-0.62 minutes and the flow rate was adjusted from 1.12 ml/min to 1.16 ml/min.Field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Device evaluation by manufacturer: the uptake check valve, pump assembly and the purge check valve were returned for investigation.Functional testing on the uptake check valve was performed and it confirmed the failure and the error was duplicated.Visual inspection of the pump assembly demenstrated corrosion and functional testing could not be performed.The pump was deemed non functional.Functional testing on the purge check valve did not confirm the failure and could not duplicate the error.The most probable cause of the reported issue was the uptake check valve and the pump assembly.Conclusion code: 4307- cause traced to component/failure.(b)(4), 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
• 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: 7653477
• MDR Text Key: 113178846
• Report Number: 8031673-2018-00565
• 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: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 07/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2018
• Distributor Facility Aware Date: 07/06/2018
• Device Age: 9 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/20/2018
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1