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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

On october 6, 2016, the fse went to the customer site to evaluate failure of the g8 analyzer.During evaluation of the analyzer, the fse found failure of the sample loop.The sample loop (short piece of peek tubing that goes from one port of the injection valve to the other is the path for the pressure) was replaced.Following repair, the fse ran controls in which results were within acceptable range.The g8 analyzer was verified for operation.The most probable cause of pressure failure and grad sensor error is due to a leak in the path for pressure.The g8 service, operator's, and training manuals were reviewed and found to clearly address calibration, operation, maintenance, error codes and troubleshooting pertaining to the g8 system.Review of the g8 analysis service manual informs the user of the following: injection valve: this valve is used to inject a sample into the assay line after sample dilution.The sample loop volume is 4 ¿l.Flow pressure will not rise (pressure low).Cause: no fluid, leak from tubing connection, pump plunger seal deterioration, defective pump check valve and 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 and 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 is too high (pressure high).Cause: column deterioration, filter clog, tubing connection clog and inj valve clog.Check point/countermeasure: remove column and make the pump run manually.If the pressure is 2 mpa or below, the column is the cause.Replace the column.If the pressure is high when the filter outlet tubing is disconnected, but normal when the filter inlet tubing is disconnected, replace the filter.Individually disconnect each connection joint and find the blockage.If a blockage is found, cut approximately 10 mm of tubing and connect again.If the blockage is in the sample loop, replace the sample loop.If you have checked blockage during the procedure (mention above) and a blockage was in the inj valve, replace the rotor seal and stator face.Error message: 150 grad sensor error.Content: the grad sensor of pump is out of order.Monitoring method: in flow condition, the grad sensor is checked whether signal value changes within 2 seconds.Cause: grad sensor fault, i/o-board fault c) main board fault.Countermeasure: inspect the grad sensor, inspect boards.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).

Event Description

On (b)(6) 2016, the customer called to report a high pressure problem and gradient sensor error with the g8 analyzer.The customer was instructed to change the filter which resulted in a change in pressure to zero.Following the customer was asked to open and close the drain valve which did not affect the pressure (pressure remained at zero).The customer then reported that the injection valve was leaking.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hba1c patient results.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: 7387776
• MDR Text Key: 104269991
• Report Number: 8031673-2018-02242
• 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: 10/05/2016
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/01/2018
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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