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

Model Number G8

Device Problems Increase in Pressure (1491); Device Issue (2379); Device Operates Differently Than Expected (2913); Pressure Problem (3012)

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

Event Date 05/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse verified the high pressure and a leak at the injector valve.The fse ran a precision and qc then calibrated the analyzer.The pressure was within an acceptable range, 8.5 mpa, and there were no additional leaks on the instrument.All results were within acceptable range.All errors cleared and the g8 instrument was operational.No further actions were required by field service.A 13-month complaint / service history review for similar complaints was performed for the serial number (b)(4) from aware date of (b)(6) 2018, which included data from 19-apr-2017 through 18-may-2018.There were three similar complaints identified during the searched period, which includes this event.The g8 operator's manual under section 6.3 error messages as follows: 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 for the reported event was blockage in the tubing from the pre-filter to i6 connecting to the injector valve.

Event Description

A customer reported a high pressure reading of 12.66 [7.3-11.3] mpa on the g8 instrument.The customer replaced the filter but that did not resolve the issue.The technical support specialist (tss) advised the customer to take pressure readings along the pathway of the sample and to replace the column.All readings were similar but replacing the column did not resolve the issue.Tss then advised the customer to disconnect the peek tubing at the i6 valve port.The customer ran the pump then reconnected the tubing and ran quality control (qc).The pressure was in range and reportable; the pressure reading was 8.29 mpa.After the pressure was reported to be in range, the customer called back to report that the instrument was down due to high pressure.The customer was unable to run patient samples on hba1c.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for 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).Correction: aware date.A 13-month complaint / service history review for similar complaints was performed for the serial number (b)(4) from aware date of (b)(6) 2018, which included data from (b)(6) 2017 through (b)(6) 2018.There were three similar complaints identified during the searched period, which includes this event.

• Brand Name: TOSOH HLC-723GA ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; tokyo, japan 10586 23; JA 1058623
• MDR Report Key: 7590800
• MDR Text Key: 111321457
• Report Number: 8031673-2018-00515
• 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: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2018
• Distributor Facility Aware Date: 08/20/2018
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/31/2018
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention