MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Difficult to Flush (1251)

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

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.A field service engineer (fse) was at the customer's site to address reported event.Fse confirmed reported error by reviewing the analyzer printouts, and reproduced error by attempting a startup.Fse resolved the complaint by replacing the bf wash probe.Fse successfully initialized the analyzer without error, performed 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 other similar complaints found during the searched period.The aia-360 operator's manual under chapter 7, section 7.1: list of error messages states the following: [2015] bf probe purge failure is generated when purging by the bf probe is abnormal.The operator is instructed to clean up the wash probe tip or replace it.Contact the service department.The most probable cause of the reported event is due to failure of the bf wash probe.

Event Description

A customer reported getting error message 2015 "bf probe purge failure" during startup of the aia-360 analyzer.Technical support specialist (tss) instructed the customer to clean the electrodes with alcohol and repeat the installation wizard to prime, but error persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for estradiol (e2).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Event Description

N/a.

Manufacturer Narrative

The bf wash probe was returned to tosoh instrument service center for investigation.Functional testing of the probe could not confirm reported event.The most probable cause of the reported event could not be duplicated.

• 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: 10820547
• MDR Text Key: 261061030
• Report Number: 8031673-2020-00338
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 10/26/2020
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1