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

Model Number G8

Device Problems Fluid/Blood Leak (1250); Pressure Problem (3012)

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

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) was dispatched to the customer's site to address the reported event.The customer informed the fse of a high pressure error.Fse verified and reproduced the complaint by turning on the pump and pressure exceeded allowable range.Fse noted clogged tubing and replaced the tubing from position 6 on the injector valve to the bottom of the pre-filter assembly.Fse also replaced the sample loop, as the ferrule had backed off at position 1 on the injector valve because of the high pressure, resulting in a leak.Fse ran quality control (qc) which completed within acceptable range and the pressure was stable at 9.5 mpa.Fse successfully completed 40 patients sample runs and pressure stayed within acceptable range.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 the serial number 13583708.There were no similar complaints identified during the search period.The g8 operator's manual, chapter 1 - introduction and applications states the following connect the tubing to the outlet side of the column.Press pump flow to start pumping and check for leaks.The pressure should rise to the pressure level that is indicated on the column inspection report + 4 mpa.If leaks occur, tighten fittings.When the pressure reaches a steady state, press pump flow again to stop pumping.From the main screen, select mainte, then reagent change.Press column reset to set column count back to zero.Before calibrating the newly installed column, run at least three whole blood samples to prime the column.Calibrate the system and run controls.In chapter 6: troubleshooting states general error messages with these errors, the assay stops and the analyzer immediately enters stand-by state.100 pressure high the pump pressure exceeded the upper limit (15 mpa) set in the pres high parameters.When the filter or column replacement period has been exceeded, first replace the filter or column.If the pressure is still high, remove the inlet and outlet flow line around the column and filter, and determine which part is the cause of the high pressure.Then, contact a technical support representative.If the pressure displayed on the screen is: (a) greater than the pressure on the column inspection report + 4 mpa, then replace the filter.(b) less than the pressure on the column inspection report, then proceed with priming the column.The most probable cause of the reported event was due to clog in tubing between i6 on the injector valve and the bottom of the pre-filter assembly.

Event Description

A customer reported a leak from position 1 of the injection valve during startup on the g8 analyzer.Customer stated the pressure was high, and then dropped.Customer attempted to tighten the injector valve but was unable to resolve the leak.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 was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Additional 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 sample loop was returned to tosoh instrument service center for investigation.Functional testing could not replicate the reported leaking and high-pressure errors.The most probable cause of the reported event was due to clog in tubing between i6 on the injector valve and the bottom of the pre-filter assembly.The probable cause of the reported issue with the sample loop could not be determined during investigation.

• 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: 8127422
• MDR Text Key: 129885723
• Report Number: 8031673-2018-05296
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• 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: 06/17/2019
• Distributor Facility Aware Date: 11/13/2018
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/17/2019
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1