MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

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

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the reported issue on the error log.Following an inspection, the fse replaced the sens board due to potentially causing intermittent issue.Additionally, the fse cleaned both p/d and b/f tables and rotors and verified all y-axis alignments.The aia-2000 instrument returned to normal operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2019 to aware date (b)(6) 2020.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: [2160] y-axis cup transfer cup detection failure.Cause: the cup-gripping sensor failed to detect a cup prior to cup pickup.The measurement result is flagged with mf or se.Solution: contact tosoh service center or local representatives.The probable cause of the issue is attributed to faulty sens board.

Event Description

A customer reported to the field service engineer (fse) receiving error 2160 y-axis cup transfer cup detection failure on the aia-2000 analyzer.A field service engineer (fse) went onsite to address the reported issue, which resulted in the delay of reporting intact parathyroid hormone (ipth) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

Manufacturer Narrative

Device evaluation: h6 result and conclusion codes the suspect sens board was returned to tosoh instrument service center for investigation.A visual inspection revealed no shipping damage.Functional testing was performed by installing the returned part onto a test bed analyzer.An attempt to replicate the reported error was performed by running cup transfer five (5) times; however, the error could not be replicated during the cup transfer testing.In addition, a precision test was performed; test results were within the acceptable range.The suspect sens board passed testing requirements.The probable cause of the issue could not be determined.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 10411560
• MDR Text Key: 206177081
• Report Number: 8031673-2020-00216
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1