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

Model Number G8

Device Problem Material Deformation (2976)

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

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) contacted the customer over the phone to address the reported event.Fse instructed the customer to obtain a spare column fitting from the accessory kit and connect it to the column.The customer ran primer samples without any leaks and the retention times were at 0.59-0.60 minutes.The customer then calibrated and ran quality controls without any issues.No further action was required by the fse.The instrument was installed on 08-mar-2018.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 08-mar-2018 through aware date (b)(4) 2018.There were no similar complaints found during the searched period.The g8 operator's manual under chapter 3, assay operations, section 7, states the following: 7.Other items to check: check the flow line connections, particularly the filter and the column inlet and outlet for leaks during warming up operations.Tighten the connection if a leak is found.The most probable cause of the reported issue was a deformed column fitting.

Event Description

A customer reported that the screw that holds the tubing to the column has detached itself on the g8 instrument.The customer stated that they could not get a tight fit and the tubing could not be advanced through the screw.The instrument was down.A field service engineer (fse) was dispatched to address the reported event, which could have resulted in delay of 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: 8229665
• MDR Text Key: 133935002
• Report Number: 8031673-2018-05417
• 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: 01/08/2019
• 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: Other
• 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