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

Model Number G8

Device Problems Mechanical Problem (1384); Failure to Align (2522)

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

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address the reported event.During evaluation, the fse confirmed a bent needle.Fse replaced the sample needle and realigned the sample rack.Fse ran rack rotations and several patient samples without any errors.Fse verified proper operation without any errors.The instrument was operating as expected.There was no further action required by fse.The instrument was installed on 28-feb-2018.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 28-feb-2018 through aware date (b)(4) 2018.There were three (3) similar complaints including this complaint 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.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 bent needle caused by misalignment of the loader position.

Event Description

A customer reported getting 710 z1-axis error messages on the g8 instrument.The customer replaced the sample needle and found that it was bent.When they replaced the sample needle, they found that the needle had bent again.The customer was concerned that the needle alignment needed to be adjusted.Technical support (ts) sent the customer a replacement sample needle.The instrument was down.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

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.A review of the device history record (dhr) was conducted for serial number (b)(4), which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported 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 10586 23; JA 1058623
• MDR Report Key: 8022423
• MDR Text Key: 126555475
• Report Number: 8031673-2018-00991
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Distributor Facility Aware Date: 01/31/2019
• Device Age: 1 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/05/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1