MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

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

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the multiple slave errors and a bf probe purge failure error on the printout.The fse could not reproduce the multiple slave errors after verifying all connections on all the pcbs, examined for any fluid leaks, performed software backup, and examined the power supplied to the analyzer via the line conditioner.Additionally, the fse investigated the bf probe purge failure error and was able to reproduce the issue.The fse primed the wash solution and reseated the supply tubing, which resolved the issue.The fse verified for air leaks; none were found.The fse then instructed the customer on how to make wash solution inside the wash bottle onboard the system versus using an outside container.Daily check procedure and qc passed with no system errors.The aia-360 analyzer returned to normal operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number 28038207 from 03jul2019 to aware date 03aug2020.One other similar complaint related to bf probe purge failure was identified during the search period.The aia-360 operator's manual states the following: [5002] no response from slave description: slave response not detected error troubleshooting: turn the power off and on again.If this problem reoccurs, contact the service department.[5003] slave command error description: slave command error.Troubleshooting: turn the power off and on again.If this problem reoccurs, contact the service department.[2015] bf probe purge failure description: purging by the bf probe is abnormal.Troubleshooting: clean up the wash probe tip or replace it.Contact the service department.The probable cause of the multiple system slave errors could not be determined.The cause of the bf probe purge failure error was due to incorrect wash solution preparation.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 error 5002 no response from slave and error 5003 slave command error while operating on the aia-360 analyzer.The customer repowered the instrument several times; however, the error persisted.An fse was dispatched.A field service engineer (fse) went onsite to address the reported issue, which resulted in the delay of reporting luteinizing hormone ii (lh ii) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• 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
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10454850
• MDR Text Key: 204874900
• Report Number: 8031673-2020-00235
• 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: 08/24/2020

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-360
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• 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