MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Obstruction of Flow (2423)

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

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed and replicated the issue by running qc on the instrument.The fse replaced the sample nozzle; however, the error persisted.The pressure sensor was then replaced and the impasse test result was acceptable but on the high end.Next, the solenoid valve on the sample syringe was replaced which brought the impasse test result near the middle, and the issue was resolved.Instrument validation was performed via quality control (qc); results were within the published ranges.The aia-360 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-360 operator's manual states the following: [4017] spec.Sy clog detected.Description: specimen clog was detected.Troubleshooting: the item is not assayed.Repeat assay.The probable cause of the issue is attributed to faulty pressure sensor and solenoid valve.

Event Description

A customer reported error 4017 spec.Sy clog detected on the aia-360 analyzer.The customer performed an all-set-home command; however, the error persisted.An fse was dispatched.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.

• 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: 10443100
• MDR Text Key: 206112452
• Report Number: 8031673-2020-00226
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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?: Yes
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1