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

Model Number G8

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

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

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineer (fse) was at customer's site to resolve reported issue.Fse inspected instrument and found damaged seal on filter fitting.Fse replaced the line filter tubing due to damaged seal at filter fitting.Fse restarted analyzer, checked pressure and tested for leaks.Fse also ran several samples to confirm analyzer is operating as intended.Customer successfully completed quality controls and sample precision.The g8 analyzer is functioning as expected.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 (b)(4).There were no similar complaints found during this time.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 event was due to damaged line filter tubing seal.

Event Description

A customer reported liquid leak and low pressure on the g8 analyzer.Customer states that after changing the pre-filter, liquid was leaking from the pre-filter housing and the tubing going into the housing was loose.Technical support specialist instructed the customer to unscrew fitting and try to retighten the fitting.Customer stated the tubing is still loose and pulls out.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.

• 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, japan 10586 23; JA 1058623
• MDR Report Key: 7920870
• MDR Text Key: 123676217
• Report Number: 8031673-2018-00896
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• 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: 03/15/2019
• Distributor Facility Aware Date: 03/12/2019
• Device Age: 8 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/15/2019
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1