MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. AIA-900

Model Number AIA-900

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was unable to confirm the error via the error log.This error assumes that the reagent door might still be open.The fse was able to reproduce the error by opening the reagent tray door and then tried to close it.The instrument would not engage the latch to close the door.The fse investigated the error by using the rt button on the instrument monitor to re-engage the latch.This demonstrated that the solenoid and key latch are functionally able to engage and that the pia-board detecting closure failed.To resolve the issue, the fse replaced the pia-board.The customer ran quality control (qc) and the analyzer was operating normally.The aia-900 analyzer is functioning as expected.No further action required by field service.Device evaluation: the pia-board was returned to tosoh instrument service center (isc) for investigation.The soldered leads to board powered up in isc test.The r27 sensor lot was monitored.The board properly changed its state on/off when flagged (eye interrupted).The field failure was unable to be replicated.The part passed during testing.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 30may2019 through aware date (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: error message: [2200] reagent/tip cover open.Cause: the reagent/tip cover opened/closed sensor s092 detected an "open" status.The operation of the reagent/tip loader was stopped.Action: if there is a problem with the cover, contact the tosoh local representatives.Check s092 and also the reagent/tip rack cover opening/closing mechanism.The most probable cause of the reported event is failure of the pi.

Event Description

Customer reported a reagent tip loader error on the aia-900 analyzer.The site is unable to update the reagents in the tip loader.The customer will press to open the tip loader and it will open as expected.When attempting to update reagents analyzer, an error occurs indicating that it cannot be updated because the door is closed and locked.The error had started about a week ago.The analyzer is down.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting intact parathyroid hormone (ipth) and 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.

Manufacturer Narrative

The probable cause could not be determined.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 10405470
• MDR Text Key: 204764685
• Report Number: 8031673-2020-00199
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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: 07/15/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1