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 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and inspected the sorter lock sensor and lock mechanism and found no issues.The sorter drawer may have not been closed far enough for the lock to engage.The fse was able to reproduce the 4053 error by running the sorter test.The fse found that the d lane needed to be realigned, and the sorter d lane position parameter adjusted within specification.The fse also saw issues with cups not having the seal broken correctly.Adjusting the d lane and associated parameters resolved the seal break and sorter z error.The fse verified this with the sorter test, cup transfer test, and the seal break 10 test.The fse used customer prepared controls.Customer accepted the quality control.The aia-900 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from of (b)(6) 2019 through aware date of (b)(6) 2020.There were no similar complaints identified during the searched period.The aia-900 operator's manual under section 12 - flags and error messages states the following: sorter drawer lock open.Cause: a sorter drawer "unlocked" status was detected during operation, causing measurement to be paused.Action: press the cup sorter key to lock the drawer.Measurement will resume.Sorter-z home overrun.Cause: the home sensor s2022, which is not supposed to be activated after the sorter z-axis moves, was activated.A retry will take place, and if there is no improvement a flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s022 and also check to see the cause of slipping, and so on, that occurs when pm022 moves to the limit side.The most probable cause of the reported sorter drawer lock open was due to the sorter not being closed properly.The most probable cause of the reported sorter z home overrun was due to misaligned sorter dispense lane positioning and seal breaker.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer reported that the sorter drawer on the aia-900 instrument opened on its own.Customer indicated that she pushed the drawer back in and attempted to run samples again.Customer then indicated that an error 4053 (sorter z-home overrun) occurred each time she attempts to run a sample.Customer stated that she performed an all set home which did not resolve the issue.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting beta human chorionic gonadotropin (bhcg) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9934313
• MDR Text Key: 228350116
• Report Number: 8031673-2020-00093
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2020
• Initial Date FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1