MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)

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

Event Date 08/22/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) sent customer a quote for service and in the meantime, the fse involved sales to give the customer an offer for a new analyzer.The fse contacted the customer via telephone and was informed by the customer that they do not want to issue a po for onsite service.Customer is looking to purchase a new aia-360 analyzer.Customer did not want to troubleshoot the issue over the phone.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from (b)(6) 2019 through aware date of (b)(6)2020.There were no similar complaints identified during the searched period.The most probable cause of this reported event is unresolved.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer reported that the display screen on the aia-360 instrument is not responding.Customer indicated that she is able to get to the substrate screen but cannot type in the amount of substrate.Customer attempted rebooting the analyzer several times.A field service engineer was dispatched to address the reported issue which caused a delay in reporting beta human chorionic gonadotropin (bhcg) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Correction: h10 probable cause is unresolved.

• 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
• MDR Report Key: 10555402
• MDR Text Key: 208339981
• Report Number: 8031673-2020-00263
• 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: 09/24/2020

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: 08/22/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1