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

Model Number G8

Device Problem Increase in Pressure (1491)

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

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) contacted the customer over-the-phone to address the reported event.Fse troubleshooted with the customer and instructed the customer to replace the column.The pressure was reading 8.98 mpa thereafter.There were no further high pressure alarms.The instrument was verified as operational.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 number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were two (2) similar complaints, including this ticket, found during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: 6.3 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 was the column needed to be replaced.

Event Description

A customer reported getting 100 pressure high error messages with a pressure of 14.56 mpa with the g8 instrument.Technical support (ts) instructed the customer to change the filter and run three drain flushes.The customer checked the pressure and it was still at 14.0 mpa.Ts then instructed the customer to remove the tubing from above the prefilter and the pressure dropped to 0 mpa.Ts asked the customer to change the filter again and made sure it was properly installed.The pressure was still at 14.0 mpa.The customer stated that they were able to see fluid coming from beneath the filter.The instrument was down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay of 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.

• 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
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 8049517
• MDR Text Key: 128388510
• Report Number: 8031673-2018-05240
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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: 11/07/2018
• Distributor Facility Aware Date: 10/25/2018
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 11/07/2018
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1