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 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) called the customer to address the reported event.The customer was able to determine that the wash tubing came off top of the wash probe which caused the leak error.The fse instructed the customer to reattach the tubing to wash probe.The customer was able to resolve the leak sensor, perform daily startup and run controls successfully and continue normal operation.The customer confirmed that the quality controls were in range.No further action required by field service.The aia-360 instrument is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 14september2018 through aware date 14october2019.There were no other similar complaints identified during the review period.The aia-360 operator's manual under section 7-1: list of error messages states the following: 3022 - leak sensor s702 detected.Description: leakage sensor s702 activated.Troubleshooting: contact the service department.2015 - bf probe purge failure.Description: purging by the bf probe is abnormal.Troubleshooting: clean up the wash probe tip or replace it.Contact the service department.The probable cause of the reported event was due to the wash probe tubing which was not connected to the probe.

Event Description

A customer reported getting error messages 3022 leak sensor s702 detected, 2015 bf probe purge failure, and 2017 substrate purge error on the aia-360 instrument.The customer first received a 2015 bf probe purge failure and then a 2017 substrate purge error.The customer observed that the tubing which should be connected to the top of the wash probe was not connected.After the tubing was connected the customer received error 3022 leak sensor s702 detected.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of beta human chorionic gonadotropin (bhcg), luteinizing hormone (lh ii), follicle stimulating hormone (fsh), prolactin (prl), and 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: 9312425
• MDR Text Key: 204703019
• Report Number: 8031673-2019-00437
• 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

• Date FDA Received: 11/12/2019
• 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: 10/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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