MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The error was confirmed on the error log and reproduced by performing a cup transfer test.The fse observed the dispense lane was unstable and vibrating, and as a result, replaced the dispense lane and cup transfer assembly.The aia-900 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 (b)(6) 2018 to aware date 15oct2019.No other similar complaints were identified during the search period.The aia-900 operator's manual states the following: [4081] d.Lane-x home not detected.Cause: the home sensor s030 failed to be activated after the dispensing lane moved toward the home position.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s030 and pm030 for a possible malfunction.The probable cause of the issue is under investigation.

Event Description

A customer reported receiving error message 4081 d.Lane-x home not detected while operating on the aia-900 analyzer.The customer performed an all set home and rebooted the system but resulted in error both times.The customer stated upon startup, a grinding noise came from the analyzer.No obvious obstruction was noted.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of estradiol (e2) and follicle-stimulating hormone (fsh) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

Additional information: h6: result and conclusion codes.The test cup lane assembly was returned to tosoh instrument service center for investigation.A visual inspection revealed the cup head had excessive wear, exceeding limits of adjustment.The most probable cause of the issue is attributed to excessive wear of the test cup lane assembly.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 9291200
• MDR Text Key: 220569332
• Report Number: 8031673-2019-00447
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930111
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1