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 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The fse was able to confirm and reproduce the issue by attempting to perform level sense and receiving error 2013.The issue was resolved by replacing pc board for the level sensor (eki board).The instrument was validated by running quality controls (qc).The qc results passed and were within published ranges.The instrument software was upgraded to version (b)(4).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 26oct2018 through aware date 26nov2019.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 and 7-2: list of flags states the following: mf: a flag is attached due to an abnormality occurring during sample dispensing.Operation continues but a return failure disables the assay.2013 - sample level detection: description: the liquid surface cannot be detected even at the bottom of the sample cup or the blood sample tube.Troubleshooting: contact the service department.The probable cause of the reported event was due to failure of the eki (pcb) board for level sensor.

Event Description

A customer reported getting a mf mechanical failure while sampling flag and error message 2013 sample level detection on the aia-360 instrument.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of beta human chorionic gonadotropin (bhcg), estradiol (e2) and luteinizing hormone (lh ii) 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: 9513206
• MDR Text Key: 219779556
• Report Number: 8031673-2019-00513
• 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: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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