MAUDE Adverse Event Report: Tosoh Bioscience, Inc. (Ohio) AIA-2000; Fluorometer, For Clinical Use

Model Number	AIA-2000ST REFURBISHED
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: AIA-2000
• Common Device Name: Fluorometer, For Clinical Use
• Manufacturer (Section D): Tosoh Bioscience, Inc. (Ohio); 3600 gantz rd; grove city OH 43123
• Manufacturer (Section G): Tosoh Bioscience, Inc. (Ohio); 3600 gantz rd; grove city OH 43123
• Manufacturer Contact: janefrances ajiduah ; 2-2-1 yaesu; chuo-ku, tokyo 10400-28 ; JA 1040028 ; +1(650)636-8314
• MDR Report Key: 50256552
• Report Number: 3005529799-2026-00008
• Device Sequence Number: 21366090
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/14/2026

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-2000ST REFURBISHED
• Device Catalogue Number: 022100R
• 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: 07/27/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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