MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. TOSOH HLC-723G8 ANALYZER G8

Model Number G8

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was dispatched to the field service engineer (fse) department for further investigation.The fse found the degasser vacuum pump failing.Fse replaced the degasser vacuum pump and ran quality controls, results were within range and without any errors.The instrument is functioning as intended and was released.No further actions are required by the fse.The g8 instrument, serial number (b)(4) was installed on the (b)(6) 2018.A complaint history review and service history review for similar complaints was performed from (b)(6) 2018 through aware date the (b)(6) 2018.There were no similar complaints found during the searched period.A review of the device history record (dhr) was conducted for serial number (b)(4), which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The g8 variant analysis mode operator's safety precautions states the following: for repair, contact technical support fires, electrical shocks and other problems may occur if the instrument is disassembled, repaired or remodeled by yourself.

Event Description

The customer reported the instrument is making loud noise during warm up.Customer indicated that there are no error codes being displayed by the instrument.The instrument was rebooted and the loud noise still occurred.Customer is unable to locate the source of the loud noise.The instrument is down and the fse was notified.Field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of hemoglobin a1c (hba1c) patient results.There was 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, (b)(4), per exemption number e2017013.Device evaluation by manufacturer.The vacuum pump was returned for further evaluation.Functional testing was performed on the vacuum pump and the reported error was duplicated.The vacuum pump failed functional testing and will be discarded.The most probable cause of the reported issue is due to the vacuum pump.

• Brand Name: TOSOH HLC-723G8 ANALYZER G8
• Type of Device: G8
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH ; JA
• MDR Report Key: 7668692
• MDR Text Key: 113393865
• Report Number: 3005529799-2018-00604
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2018
• 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: 06/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2018
• Distributor Facility Aware Date: 11/10/2018
• Date Report to Manufacturer: 11/20/2018
• Date Manufacturer Received: 11/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1