MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-360; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2021

Event Type  malfunction  

Event Description

A customer reported getting error message 4044 wash sy home not found on the aia-360 analyzer.Technical support specialist (tss) asked the customer to reboot the analyzer, but error persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for estradiol (e2).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by reviewing the error logs and reproduced error by bf wash prime.Fse found debris on the feed screw for the wash that indicated it was misaligned and digging into the block around the feed screw.Fse replaced the feed screw, which includes the block.Fse performed multiple wash primes without error and quality control run was completed, results were within acceptable range.No further action required by field service.The aia-360 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no other similar complaints found during the searched period.The aia-360 operator's manual under chapter 7, section 7.1: list of error messages states the following: [4044] wash sy home not found is generated when the bf syringe motor home position cannot be detected.The operator is instructed to turn the power off and on again.If this problem reoccurs, contact the service department.The most probable cause of the reported event is due to damaged wash lead screw/block.

• Brand Name: AIA-360
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• MDR Report Key: 12716331
• MDR Text Key: 283829087
• Report Number: 3004529019-2021-00059
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• 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
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1