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

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) went to the customer site to evaluate the problem.The fse performed pm.During pm, the fse replaced the syringe tip and lubricated the syringe assembly.After pm was completed, error code 707 recurred during shutdown.The fse replaced the sys motor and ran eleven (11) patients to test operation; however, error 707 persisted after run was completed and switched to stand-by.The fse returned on 27-sep-2016 to replace the drv2 board.Following the fse ran qcs and patients samples without error.The fse verified operation of the g8 analyzer and it was ready for use.The most probable cause of the reported problem is related to failure of the drv2 board.The g8 service, operator's, and training manuals were reviewed and found to clearly address calibration, quality controls, operation, maintenance, error codes, and troubleshooting pertaining to the g8 system.The g8 operator's manual informs the user of the following: error message: 707 syringe-s error.Explanation: operation error in syringe-s.Countermeasure: inspect syringe-s.Execute smp.Reset.707 syringe-s error: content: operation error in syringe-s.Monitoring method: unexpected home sensor and limiter sensors signals are monitored.During syringe s operation (refer to error log in "4.10 how to read the log").Causes: a) incorrect syringe s operation b) sys motor fault c) sys-u sensor fault d) sys-d sensor fault e) drv2 board fault f) asm board fault.Countermeasures: a) inspect syringe s b) inspect the sys motor c) inspect sensors d) 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 tosoh technical support (tts) to report receiving error code 707 (small syringe errors) during use of the g8 analyzer.The customer requested a field service engineer (fse) come on-site to perform preventive maintenance (pm) on the g8 analyzer.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: 7387772
• MDR Text Key: 104271278
• Report Number: 8031673-2018-02241
• 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: 06/17/2016
• Device Age: 6 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/01/2018
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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