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 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The fse was able to confirm the error by reviewing the error log.The error was reproduced by trying to home the instrument.The fse replaced the test cup picking assembly and the drv-board.The instrument then operated as expected and was returned to use.The instrument software was upgraded to software version (b)(4) per technical bulletin aia-900-t121(e).No further action required by field service.The aia-900 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 10september2018 through aware date 10october2019.There were no other similar complaints identified during the review period.The aia-900 operator's manual under section 12 flags and error messages states the following: 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 probable cause of the reported event is pending investigation completion.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported getting error message 4151 c.Trans-z home detect error on the aia-900 instrument.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of beta human chorionic gonadotropin (bhcg) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

The cup pick up assembly was returned to tosoh instrument service center for investigation.Visual inspection confirmed the reported issue was due to failure of the cup pick up assembly.The drv bd (part # 022951) was returned to tosoh instrument service center for investigation.Functional testing could not confirm the reported issue was due to failure of the drv bd as the error could not be duplicated.The probable cause of the cup pickup failure was due to faulty cup pick up assembly.The probable cause of the drv board failure was not determine; reported error could not be duplicated.

• 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: 9297497
• MDR Text Key: 219790861
• Report Number: 8031673-2019-00431
• 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: 11/19/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1