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

Model Number G8

Device Problems Decrease in Pressure (1490); Device Displays Incorrect Message (2591)

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

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fse arrived at the site to address the reported event.Fse confirmed the reported event via the error log; however, was unable to duplicate the issue while on site.When fse performed a drain flush and turned the pump on, device pressure increased to 8.27 mpa.Next, fse ran some patient samples and adjusted the flow rate for sa1c retention time (rt) of 0.59.The customer was subsequently able to run quality control (qc) and patient samples without errors.No further issues were noted.No further action was required by field service.A 13 month complaint history review and service history review for similar complaints was performed for the serial (b)(4) from 12may2017 through aware date (b)(6) 2018.There were no similar complaints identified during the search period.The g8 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.101 pressure low: the pressure will not rise because the pump is unable to run due to air bubbles in the pump check valve.If the elution buffer is empty, place a new elution buffer and execute reagent change.Next, execute drain flush.See "chapter 5 section 5.5: pump air removal".Execute manual pumping using the pump key in the main screen (second screen), and open and close the drain valve 2 or 3 times.If the pressure rises when the drain valve is closed, the operation is complete.If the pressure still does not rise or stabilize, execute drain flush again.In addition, confirm that the drain valve is securely closed.The most probable cause of the reported event remains unknown as the reported event could not be duplicated.

Event Description

It was reported that the customer experienced low pressure, "101 pressure low", with their g8 analyzer.The customer attempted to troubleshoot by performing several drain flushes and changing the filter; which increased the pressure momentarily before dropping down to 0.0 megapascals (mpa).Technical support (ts) instructed the customer to verify buffers were in the buffer bags and that the tubing was correctly placed all the way down in the bags.Ts also had the customer inspect the device to verify that the tubing was secured on either side of the column and the filter.No leaks were observed.When the customer rebooted the device, pressure was again 0.0 mpa.The customer was then instructed to open and close the drain valve and remove the buffer filters; however, the issue persisted.The customer was unable to run hemoglobin aic (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 was 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: 7653262
• MDR Text Key: 113249226
• Report Number: 8031673-2018-00611
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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: 06/29/2018
• Distributor Facility Aware Date: 06/12/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/29/2018
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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