MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

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

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineering (fse) was at the customer's site to resolve reported event.Fse confirmed reported error by reviewing analyzer print out.Fse was able to reproduce the reported event by running a substrate replacement.Fse resolved the complaint by replacing the 3 way solenoid valve; fse also replaced the syringe tip.Fse performed quality control run to validate the analyzer, run completed without error and 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 training manual, tab 8: troubleshooting 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 faulty 3-way solenoid valve.

Event Description

A customer reported getting error message "2017 substrate purge failure" during aia-360 analyzer shutdown.Technical support specialist (tss) instructed the customer to put fresh alcohol in the bottle and try to do a replace substrate from the maintenance, operation failed with error 2017 reoccurring.Customer attempted shutdown again, error persisted.A field service engineer (fse) was dispatched to address the reported event, which resulted in a 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.

• 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: 10568168
• MDR Text Key: 208013117
• Report Number: 8031673-2020-00277
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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: 06/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• 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