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 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed reported error by reviewed the error log and was able to reproduce the error by attempting to perform an all set home operation.While troubleshooting, fse found the z-axis stepper motor on the cup transfer assembly to be faulty and replaced it.Fse successfully performed quality control to validate the analyzer, results were without error and within acceptable range.No further action required by field service.The aia-900 analyzer is functioning as expected.The z -axis stepper motor on cup tranfer assembly was returned to tosoh instrument service center for investigation.Functional testing confirmed the reported failure.The aia-900, serial number (b)(4), was installed on 17oct2019.A complaint history review and service history review for similar complaints was performed from installation date through aware date.There were no other similar complaints identified during the searched period.The aia-900 operator's manual under section 12 - flags and error messages states: [4151] c.Trans-z home detect error.Cause: the home sensor s062 failed to be activated after the transfer y 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 s062 and pm061 for a possible malfunction.The most probable cause of the reported event was due to faulty cup transfer z-axis motor.

Event Description

A customer reported getting "4151 c.Trans-z home detect error" on the aia-900 analyzer.Technical support specialist (tss) instructed the customer to inspect the cup waste chute and cup claws to confirm no reagent cups are jammed, none was found.The customer performed an all set home function, but error persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delay of luteinizing hormone (lhii) and beta human chorionic gonadotropin (bhcg) results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number (b)(6) , which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.

• 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: 10368816
• MDR Text Key: 261062370
• Report Number: 8031673-2020-00212
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1