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

Model Number	AIA-360 IMMUNOASSAY ANALYZER
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 13-month retrospective review identified 47 similar complaints.There were 27 complaints related to 2015 bf probe purge failure, 15 with 2017 substrate purge failure error, and 5 for 3021 leak sensor s701 detected.An assessment of the data determined that 41 complaints were unique with varied failure modes consisting of no flow (3), operational problem (7), improper procedure (4), loose connection (4), dust problem (2), decreased pump speed (2), priming problem (10), biological contamination, leakage (2), obstruction of flow (3), lubrication problem, cause not established, failure to deliver (2), use of device problem, mechanical problem (2), and no device problem found.Most issues were resolved with additional priming, maintenance, reseating tubing, cleaning obstructions, component replacement (i.E., probe tips, diluent pumps, sample nozzle, waste pump, etc.), and one instance of analyzer replacement.There is no indication of a systemic issue or component wide failure.

• 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: 50268899
• Report Number: 3004529019-2026-00114
• Device Sequence Number: 10316067
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/17/2026

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
• 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: 07/21/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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