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 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.A field service engineer (fse) visited the customer to address the reported event.The fse confirmed reported event and reproduced the problem by trying to reboot the analyzer.Fse resolved the reported problem by replacing the display unit.Analyzer was validated by entering data on screen.Qc was completed successfully 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 most probable cause of the reported event was due to faulty touchscreen.

Event Description

A customer reported the touch screen is not working on the aia-360 analyzer.The customer rebooted 3 times, but the reboot did not resolve to problem.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delay of beta human chorionic gonadotropin (bhcg), progesterone (progii), luteinizing hormone (lhii) and estradiol (e2) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

Corrected data: section g4 was updated from (b)(6) 2019 to (b)(6) 2019.

Event Description

N/a.

• 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
• MDR Report Key: 9930676
• MDR Text Key: 261052291
• Report Number: 8031673-2020-00107
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 08/13/2019
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1