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 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) followed up with the customer over the phone to address the reported event.While trouble shooting over the phone with the customer, the fse was able to confirm the reported error 3021 was in the error log.The error could not be reproduced because error occurred intermittently.The fse was unable to identify the cause of the leak or duplicate the error.The fse advised the customer to check for kinks in the waste tubing and to make sure that when replacing the waste tubing cap there are no kinks.No further action required by field service.The aia-360 instrument is functioning as expected.The aia-360, serial number (b)(4), was installed at the account on 01march2019.A complaint history review and service history review for similar complaints was performed from 01march2019 through aware date 17october2019.There were no other complaints identified during the searched period.The aia-360 operator's manual under section 7-1: list of error messages states the following: 3021 leak sensor s701 detected.Description: leakage sensor s701 activated.Troubleshooting: contact the service department.The probable cause of the reported event could not be duplicated.

Event Description

A customer reported getting error message 3021 leak sensor s701 detected on the aia-360 instrument.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of estradiol (e2) patient results.There was no indication of patient intervention or adverse health consequences due to the 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 (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: ms. oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9312420
• MDR Text Key: 204719100
• Report Number: 8031673-2019-00458
• 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: 11/12/2019

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: 10/17/2019
• Initial Date FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2018
• 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