MAUDE Adverse Event Report: Tosoh Hi-Tec, Inc. AIA-360; Fluorometer, For Clinical Use

Model Number	AIA-360 IMMUNOASSAY ANALYZER
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 13 month complaint history review and lot history review for similar complaints was performed for the bio-rad lot 1004820 from (b)(6)2025 through the aware date (b)(6)2026.There were no similar complaints identified during the searched period.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for "failure mode high quality control for beta human chorionic gonadotropin (bhcg)".There were nine (9) similar cases, including this one.Data assessment indicated the reported events were mostly due to biological contamination, improper procedure, incorrect interpretation of results, operational problem and/or suction problem.All quality controls were completed successfully without issues before resuming patient sample testing, confirming analyzer functionality.There was no indication of incorrect results being generated due to fault or failure of the operation of the aia-360 analyzer nor was a systemic issue identified.

• Brand Name: AIA-360
• 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: 50216919
• Report Number: 3004529019-2026-00110
• Device Sequence Number: 20357969
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• 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