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

Model Number G8

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 06/06/2018

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 replaced the asm board.The system then displayed x1 errors because the asm board was bad.The fse replaced the drv2 board.The fse tested the system and ran quality control (qc).All results were within acceptable range.All errors cleared and the g8 instrument is operational.No further action is required by field service.The parts for the driver#2 pc board and the asm pc board were returned to tosoh and were evaluated.The driver # 2 pc board was installed into a refurbished g8 testbed.The technician activated the sample head to allow the sample head to travel on the y-axis rail and the z-axis rail.Although the sample head should be able to travel on the y-axis and utilize the z-axis when commanded to, the y-axis stalled and would not move down the rail.This error was duplicated.The hybrid power module on the driver card for the y-axis was not functional.This part failed.The asm pc board was installed on the g8 refurbished testbed to activate the instrument.The asm board failed to load when the technician attempted to download the software.The asm board was non-functional.There was an internal problem with this board.This part failed.Both parts were disposed.A 13-month complaint / service history review for similar complaints was performed for the serial (b)(4) from aware date of (b)(6) 2018, which included data from 6 may 2017 through (b)(6) 2018.There were two similar complaints identified during the searched period, which includes this event.The g8 operator's manual under chapter 6 troubleshooting as follows: error message: 709 y1-axis error.Explanation: operation error in y1-axis.Countermeasure: inspect y1-axis.Execute smp.Reset.The most probable cause for the reported event was the failure of the drv2 and asm pc board.

Event Description

A customer reported that during a run on the g8 instrument, the sample assembly did not move forward enough to position the sample needle correctly over the tube.The sample assembly made a grunting noise and started to move, then stopped.The racks moved normally.The customer also reported a 709 y1-axis error and the sample needle was bent.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.

• Brand Name: TOSOH HLC-723GA 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; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo, japan 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; ste. 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 7646117
• MDR Text Key: 112891727
• Report Number: 8031673-2018-00586
• 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: 06/28/2018

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: 06/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2018
• Distributor Facility Aware Date: 06/06/2018
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/28/2018
• Date Manufacturer Received: 06/06/2018
• 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