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

Model Number G8

Device Problems Decrease in Pressure (1490); Pressure Problem (3012)

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

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Field service engineering (fse) visited the customer to address the reported event.Fse found system would not produce pressure with all three buffer valves open.Fse checked for leaks, checked connections and solenoid valves.Fse replaced check valves on pump, ran pump to get air out of the lines.Pump pressure is at 7.48 mpa.The customer successfully completed quality control run.No further action required by field service.The g8 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4).There were three (3) similar complaints identified during the searched period, which includes this event.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.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.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 was due to failure of the check valves on pump.

Event Description

A customer reported getting 101 pressure low error messages on the g8 instrument.The customer checked for leaks and none was visible.The customer changed the column and filter, and the flow factor is 1.07, buffer volumes are sufficient.The customer performed the drain flush three times and pressure increased to 7.8mpa, but later dropped to 0.0mpa.The low pressure error persisted and customer is unable to run patient samples.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of 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, japan 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368123
• MDR Report Key: 8020380
• MDR Text Key: 126664349
• Report Number: 8031673-2018-00976
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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: 10/30/2018
• Distributor Facility Aware Date: 10/12/2018
• Device Age: 7 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/30/2018
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2011
• 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