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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the reported event.During the initial evaluation, the high pressure error was confirmed.Fse observed a pressures of 6 mpa with the pump running and the filter out.Fse found that the peek tubing 1-6 and sample loop were partially clogged.The rotor seal and stator face were showing wear.Fse then replaced the rotor seal, stator face, sample loop, and the peek tube 1-6 to filter housing.A patient sample was used to validate the repair.The instrument was calibrated and controls were run with acceptable results.The g8 instrument was verified as operational.No further action was required by the 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 no similar complaints found.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: the 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.The 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 due to a clogged peek 1-6 tubing and sample loop.

Event Description

A customer reported getting error 100 pressure high with the g8 instrument.The customer reported the pressure was 11.8 mpa and the column reported high pressure of 10.8 mpa.The customer replaced the filter but the error persisted.The customer performed a drain flush and the pressure was 11.5 mpa.Technical support (ts) sent the customer a new column to troubleshoot the issue.The customer was unable to run samples.The customer changed the column and the high pressure persisted.Ts instructed the customer to remove the filter and the pressure dropped to 6.01 mpa.A 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.

• 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: 7551612
• MDR Text Key: 110127617
• Report Number: 8031673-2018-00501
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2018
• Distributor Facility Aware Date: 05/16/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 05/29/2018
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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