MAUDE Adverse Event Report: Tosoh Hi-Tec, Inc. AIA-900; Fluorometer, For Clinical Use

Model Number	AIA-900
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported the "sorter door will not close" on the aia-900 analyzer.The customer stated some test cups fell into the sorter and were obstructing the door.The customer is unable to clear the obstruction.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for creatine kinase mb isoenzyme (ck-mb) and cardiac troponin i (ctnl 2).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
Additional Manufacturer Narrative
A field service engineer (fse) contacts the customer by phone and confirmed the reported issue.The customer stated visually identifying fallen test cups within the sorter.The fse instructed the customer to remove the fallen test cups which resolved the reported issue.The sorter door is now closing as expected.No further action required by field service.The aia-900 analyzer is operating as expected.A 13-month complaint history review and service history review for similar complaints was performed for the failure mode "sorter door not closing" for the aia-900 analyzer from (b)(6) 2025 through aware date 28aug2026.There were two (2) similar complaints identified during the searched period, which includes this event.The most probable cause was due to an obstruction within the sorter, component failure.

• Brand Name: AIA-900
• Common Device Name: Fluorometer, For Clinical Use
• Manufacturer (Section D): Tosoh Hi-Tec, Inc.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): Tosoh Hi-Tec, Inc.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: janefrances ajiduah ; 2-2-1 yaesu; chuo-ku, tokyo 10400-28 ; JA 1040028 ; +1(650)636-8314
• MDR Report Key: 50797400
• Report Number: 3004529019-2026-00132
• Device Sequence Number: 10529399
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K971103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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
• Operator of Device: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930
• Device Lot Number: na
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown