MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problems Leak/Splash (1354); Mechanical Problem (1384)

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

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) followed up with the customer via telephone and spoke with someone in the lab and advised customer to look at the base of the carousel and look for any leaks.Customer did not see any and indicated that they would contact technical support if they had any other issues/problems.The fse followed up with the customer again two weeks later and customer had mentioned that they had run the aia-360 during a thyroid procedure and the analyzer functioned properly.The aia-360 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 21aug2019 through aware date (b)(6) 2020.There were no similar complaints identified during the searched period.The aia-360 operator's manual under section 7-1: list of error messages states the following: [3022] error message: leak sensor s702 detected.Description: leakage sensor s702 activated.Troubleshooting: contact the service department.The most probable cause of the reported event is unknown.

Event Description

Customer reported an error 3022, leak sensor s702 detected on the aia-360 analyzer.The technical support specialist (tss) advised the customer to turn off the analyzer, check the wash well and the sample needle.The sample needle is good.Customer dried out the wash well and performed an all set home.Customer was still getting the error 3022.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting beta human chorionic gonadotropin (bhcg) and cardiac troponin i (ctnl2) patient samples.There was 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, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 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: 10684007
• MDR Text Key: 229999695
• Report Number: 8031673-2020-00301
• 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: 10/15/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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