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

Model Number G8

Device Problems Complete Blockage (1094); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) went to the customer site to evaluate the problem and perform preventive maintenance (pm) on the g8 analyzer.Following, the fse performed calibration, ran quality controls and did precision testing on the g8 analyzer.Operation of the g8 analyzer was verified and placed back into use.Per the service report no large syringe error code occurred.It is believed that the sampling needle was clogged which prevented the syringe from pushing fluid out of the needle.Replacing of the clogged needle with a new one, the system was able to flush through the needle as expected.The most probable cause of the reported event is related to clogging of the specimen nozzle.Review of the g8 variant analysis operator's manual indicates the error message "706 syringe-l error is an operation error in syringe-l.Counter measure: inspect syringe-l.Execute smp.Reset.Error level 2: enter wash state.Alarm level 1: beep for 30 sec and turn on error led & patolight® (optional).Review of the tosoh automated glycohemoglobin analyzer g8 service manual for 706 syringe-l error addresses the following information: content: operation error in syringe-l monitoring method: unexpected home sensor and limiter sensor signals are monitored during syringe l operation cause: a) incorrect syringe l operation b) syl motor fault c) syl-u sensor fault d) syl-d sensor fault e) drv2 board fault f) asm board fault countermeasure: a) inspect syringe l b) inspect the syl 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 to report getting a large syringe error code 706 during use of the g8 analyzer.The customer further reported that they already replaced the sampling needle for this issue.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: 7347884
• MDR Text Key: 103165518
• Report Number: 8031673-2018-02226
• 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: 03/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2018
• 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: 03/18/2018
• Distributor Facility Aware Date: 06/08/2016
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/18/2018
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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