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

Model Number G8

Device Problems Increase in Pressure (1491); Device Issue (2379); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Pressure Problem (3012)

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

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A field service engineer (fse) was dispatched to the customer's facility to address the reported event.The fse confirmed the complaint when he turned on the analyzer.The pressure error displayed on the analyzer.The fse began to troubleshoot and resolved the reported event by replacing the i-6 to filter peek tubing.Retention time minutes before adjustment was 0.59.Retention time minutes after adjustment was 0.59.Retention time minutes range 0.57 - 0.61.A patient sample was used to validate and repair the retention time minutes.The fse validated the analyzer by running quality control (qc).All errors cleared and the g8 instrument is operational.No further action is required by field service.A 13-month complaint / service history review for similar complaints was performed for the serial number (b)(4) from aware date of (b)(6) 2018, which included data from 7 may 2017 through 7 june 2018.There were no similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 6 troubleshooting is as follows: the 102 pres limit over- the pump pressure has risen abnormally and has caused the shutdown circuit to be activated.Turn the main power switch off and remove the cause of the pressure increase.Refer to 100 pressure high.The most probable cause for the reported event was the clogged i-6 to filter peak tubing.The clogged samples were occluding the peek tubing.

Event Description

A customer reported error 102 pressure limit over on the g8 analyzer.The customer was advised by technical support (ts) to change the column because the column count was at 4500.The customer changed the column and she was able to calibrate and run patients without any problems.The following day, the customer turned on the analyzer and the analyzer displayed the error message.The customer shut down the analyzer a few times but couldn't get anything to work because of the error.Ts advised the customer to remove the column and try starting the analyzer but the error persisted.The customer is unable to run patient samples on 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 is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

(b)(4), per exemption number e2017013.This report is being submitted due to an internal nonconformance identified.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Device evaluation: the i-6 and peaking tube were returned for investigation to the instrument service center (isc).Visual inspection showed that the returned part was cut.Functional testing could not be performed due to the observed damage.

• Brand Name: TOSOH HLC-723GA ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; tokyo, japan 10586 23; JA 1058623
• MDR Report Key: 7646104
• MDR Text Key: 113008688
• Report Number: 8031673-2018-00590
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K071132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2018
• Distributor Facility Aware Date: 06/20/2018
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 08/02/2018
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1