MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 11/02/2020

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.Device evaluation by manufacturer: a field service engineer (fse) followed up with the customer over the phone.While troubleshooting with the customer, fse confirmed reported error by reviewing the error logs, and reproduced error by running bf wash, and substrate primes in maintenance.Customer reconfirmed disconnected tubing and reconnected it to the bf probe.The customer successfully 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 aia-360 training manual under tab 8: analyzer error codes states the following: [2017] substrate purge failure is generated when no substrate was dispensed at daily maintenance.The operator is instructed to check substrate level and replace as necessary, repeat daily maintenance.The most probable cause of the reported event is due to disconnected bf wash probe tubing.

Event Description

A customer reported getting error messages 2015 "bf probe purge failure", and 2017 "substrate purge failure" on the aia-360 analyzer.The customer also reported fluid around the carousel when clearing the quality control cups, and noted tubing to bf probe was found disconnected.Analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for luteinizing hormone (lhii), follicle stimulating hormone (fsh), progesterone (progii), estradiol (e2) and beta human chorionic gonadotropin (bhcg).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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 oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10843720
• MDR Text Key: 216915336
• Report Number: 8031673-2020-00353
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2006
• 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