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

Model Number G8

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: on 07-mar-2018, a field service engineer (fse) confirmed the 706 syringe-l error message on the g8 instrument.The fse checked all fluidic lines and found no obstructions.On 08-mar-2018, the fse replaced the asm board, ran warm up, calibration, quality controls, and patient samples without any further error.The g8 instrument was working as intended; no further action was required by the fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2016 through aware date (b)(6) 2018.There were no other similar complaints identified during the searched period.The g8 variant analysis mode operator's manual under chapter 6, troubleshooting, states the following: error messages: when consulting with technical support about a problem, please note the error message and error number.In addition, if you follow the suggested solutions in this section and are still unable to resolve the error, or if you encounter an error message that is not noted, contact technical support.General error messages: with these errors, the assay stops and the analyzer immediately enters stand-by state.705 rack pos error (rack position error).The sample rack was not properly transferred.Set the rack in the correct position and start again.If you touch or move a rack during an assay run, this error may occur.Do not touch the racks or primary tubes during an assay run.The 710 z1-axis error: an abnormality occurred in the up and down movement of the sampling needle.If this occurs during a stat assay, check that the container setting (cup or tube) is correctly set.The error also occurs when the sample vial was not recognized as a primary tube, due to the disoriented sample sensor.The most probable cause of the reported event was due to a faulty asm board.

Event Description

On (b)(6) 2018, a customer reported getting 705 rack position and 706 syringe-l error messages while running patient samples with the g8 instrument.The customer reporting hearing a grinding noise behind the sampling needle assembly as the second patient sample was ready to be aspirated.The customer was able to clear the 705 rack position error message by rotating the rack.The customer requested service in order to address the issue.A field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hemoglobin a1c (hba1c).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Device evaluation by manufacturer: the asm board was returned for investigation.Functional testing was peformed on the asm board, the error was duplicated and it confirmed the failure.Updated: pma/510k.Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 105-8 623; JA 105-8623
• MDR Report Key: 7398377
• MDR Text Key: 104699135
• Report Number: 8031673-2018-00259
• Device Sequence Number: 1
• Product Code: LCP
• Combination Product (y/n): N
• PMA/PMN Number: K131580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• 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: 04/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2018
• Distributor Facility Aware Date: 04/12/2018
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/19/2018
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1