MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineering (fse) was at the customer's site to address reported event.Fse confirmed reported errors by reviewing the error log and reproduced error by restarting the analyzer.Fse resolved the complaint by replacing the main board.Fse reinstalled the 1.39s software, restored the parameters from the customers smart card and successfully performed calibration run.The customer successfully completed quality control run without error and results were within acceptable range.No further action required by field service.The aia-360 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no similar complaints identified during the search period.The aia-360 operator's manual under section 7-1: list of error messages states the following: [5032] csum error (errlog) is generated when there is an error log checksum error.Solution: turn the power off and on again.If this problem reoccurs, contact tosoh service center or local representatives.The most probable cause of the reported event is due to failure of the main board.

Event Description

A customer reported getting "5032 csum error (errlog)" and several main board errors on the aia-360 analyzer.The customer rebooted the analyzer several times, but errors persisted upon analyzer start up.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for intact parathyroid hormone (ipth).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

The main cpu pc board was returned to tosoh instrument service center for investigation.Functional testing confirmed the reported event was due to failure of the main board.The most probable cause of the reported event was due to failure of the main board.

Event Description

N/a.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 11020725
• MDR Text Key: 230000301
• Report Number: 8031673-2020-00389
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360
• Device Catalogue Number: 019945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1