MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

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

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed fluid in the overflow tubing.The fse replaced the b/f waste valve, drain port valve, and the waste pump and resolved the issue.Inspection of the overflow chamber showed it was clean.Quality control (qc) was performed and values were within range.No fluid was observed in the overflow tubing after qc.The aia-360 analyzer operated as expected and returned to operation.No further action required by field service.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4), from 16sep2018 to aware date 16oct2019.No other similar complaints were identified during the search period.The aia-360 operator's manual states the following: preventing leakage of fluids.Leakages of assay solutions and wash solutions are potential sources of corrosion, electrical shock or even fire.When fluid leakage is discovered, immediately shut down system operation and remove the power plug.It is recommended that proper protective wear (goggles, gloves, masks, etc.) be worn at all times when cleaning up the leakage and inspecting and repairing the tubing connections that may be the source of the leak.Should the system continue to leak, contact the nearest tosoh service counter.The probable cause of the issue is under investigation.

Event Description

A customer reported fluid leak coming from the back of the aia-360 analyzer.And further stated the leak was coming from the tube that is normally dry.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of troponin i (ctnl2) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

Device evaluation: h6: updated result and conclusion codes the waste pump was returned to tosoh instrument service center for investigation.Functional testing was performed.The returned wash pump was installed on a test bed analyzer in attempt to replicate the issue - primed wash for the wash nozzle and completed the sample nozzle washing two times.The issue could not be replicated during wash priming and nozzle washing.Additionally, a precision test was performed.All results were within range.Two 2-way solenoid valves were returned to tosoh instrument service center for investigation.Functional testing was performed.The returned 2-way solenoid valves were installed on a test bed analyzer in attempt to replicate the issue - primed wash for the wash nozzle and completed the sample nozzle washing two times.The issue could not be replicated during wash priming and nozzle washing.Additionally, a precision test was performed.All results were within range.The probable cause of the issue could not be determined.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 9291212
• MDR Text Key: 220346511
• Report Number: 8031673-2019-00450
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1