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

Model Number G8

Device Problems Increase in Pressure (1491); Pressure Problem (3012)

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

Event Date 10/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) arrived at the customer's site to resolve reported event.Fse ran a pressure check, observed pressure at 13.40mpa.Fse forced out compressed air through the internal peek tubing.Fse replaced the purge and uptake check valves, ran quality control which passed with results for 2 levels in range.Fse observed the customer run 50 patient samples with no high pressure errors.No further action required by field service.The g8 instrument is functioning as expected.The g8, serial number (b)(4), was installed on 25-jul-2018.A complaint history review and service history review for similar complaints was performed.There were no other similar complaints identified during the searched period.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.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: greater than the pressure on the column inspection report + 4 mpa, then replace the filter.Less than the pressure on the column inspection report, then proceed with priming the column.The most probable cause of the reported event is pending investigation completion.

Event Description

A customer reported getting 100 pressure high error message during a run with the g8 instrument.Technical support specialist (tss) instructed customer to change filter, but error persisted.Tss instructed customer to remove filter tubing and pressure was at 3.0 mpa.Customer then removed left and right side of column tubing and pressure was the same at 3.0 mpa.The customer reconnected and ran patient samples and the pressure increased to 11-13 mpa and no errors messages occurred.The column count (cc) was 1630.Customer attempted instrument reboot at the flip switch, but the high pressure alarms.Field service engineer (fse) was dispatched to address the reported event.The event was likely to cause discrepant 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

(b)(4).A review of the device history record (dhr) was conducted for serial number (b)(4), which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.

Event Description

N/a.

Manufacturer Narrative

(b)(4) is submitting on behalf of the foreign manufacturer, (b)(4) per exemption number e2017013.Device evaluation by manufacturer.The purge and uptake check valves were returned to tosoh instrument service center (isc) for investigation.Functional testing did not confirm the failed valves.Parts will be discarded.The most probable cause of the reported event is unknown.

• 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: 8011488
• MDR Text Key: 126659234
• Report Number: 8031673-2018-00972
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2018
• 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?: Yes
• Date Returned to Manufacturer: 10/24/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2019
• Distributor Facility Aware Date: 01/31/2019
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/14/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1