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 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) contacted the customer via telephone to address the reported issue.The fse was able to confirm the error by having customer run a sample and error 2300 appeared.The fse was also able to reproduce the error by having the customer run a sample and the error 2300 also appeared.The issue was resolved by walking the customer through a re-aligning flag for s071 pitch sensor.The fse also had the customer run a rack rotation followed by a patient without error.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 10jul2019 through aware date 10aug2020.There were no similar complaints identified during the searched period.The aia-900 operator's manual: flags and error messages states the following: error message: [2300] s.Loader step feed failure.Cause: the pitch sensor s071 failed to go on after the step feed.Action: check to see if there is any impediment to the sample rack feed.If the trouble reoccurs, contact the tosoh local representatives.Check s071 and the step feed mechanism.The most probable cause of the reported event is that the pitch sensor needed to be re-aligned.

Event Description

Customer reported sample rack feed errors on the aia-900 analyzer and customer is unable to process any sample racks through the analyzer.The technical support specialist (tss) advised customer to clear all sample racks, and to perform an all set home and to reboot, however, the issue persisted.A field service engineer was dispatched to address the reported issue, which caused a delay in reporting cardiac troponin i (ctnl2) 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

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.

Manufacturer Narrative

Correction: h10 a complaint history review and service history review for similar complaints were performed for the serial number: (b)(6) from installation date on (b)(6) 2020 through aware date on (b)(6) 2020.There were no similar complaints identified during the searched period.

Manufacturer Narrative

Correction: d4: catalog number.

• 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
• MDR Report Key: 10485564
• MDR Text Key: 214347349
• Report Number: 8031673-2020-00242
• 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,Followup,Followup
• Report Date: 01/14/2021

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
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/14/2020; 11/05/2020; 01/14/2021
• Supplement Dates FDA Received: 09/14/2020; 11/05/2020; 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1