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

Model Number G8

Device Problems Mechanical Problem (1384); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) arrived at the customer site on the same day and identified air bubbles in the tubing between the 2 way solenoid valve #3 and the pump.The valve was replaced.Following the drain was flushed twice and the pressure returned.The fse ran precision and controls, and verified the g8 analyzer to be operational.The most probable cause of the pressure dropping to zero is related to a defective opening/closing mechanism of solenoid valve which most likely created air bubbles in the tubing resulting in inadequate pressure.The g8 service, operator's, and training manuals were reviewed and found to clearly address calibration, controls, operation, maintenance, error codes and troubleshooting pertaining to the g8 system.Review of the g8 variant analysis mode operator's manual informs the user of the following: pump: the pump uses the plunger method to deliver the elution buffer required for the assay.The pump operates continuously to deliver the elution buffer during the assay and feeds three different concentration elution buffers in 1.6 minute cycles by switching the solenoid valves.It also forms a gradient and the hemoglobin fractions are separated by the column.Flow pressure will not rise (pressure low) cause: no fluid, leak from tubing connection, pump plunger seal deterioration, defective pump check valve or defective opening/closing mechanism of solenoid valve check point / countermeasure: replace elution buffers with new fluids and execute reagent change, tighten various tubing connections, replace plunger seal, replace the check valve or 5) execute reagent change for all fluids and confirm that no air is entering from the solenoid valve.If air is entering, replace the suspect valve.Flow pressure will not stabilize cause: pump plunger seal deterioration or defective pump check valve check point / countermeasure: replace plunger seal or replace the check valve.The pump check valve is the same as the g7 check valve.(b)(4) is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number (b)(4).This report is being submitted due to a retrospective review conducted under capa(b)(4).

Event Description

On (b)(6) 2017, the customer contacted tosoh field service to report that while the g8 analyzer was in use, the pressure dropped to zero.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of patient results for hba1c.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: 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 (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court, ste 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7387866
• MDR Text Key: 104268828
• Report Number: 8031673-2018-02244
• 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: 04/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2018
• 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: 04/01/2018
• Distributor Facility Aware Date: 05/23/2017
• Device Age: 4 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/01/2018
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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