MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number	AIA-2000ST
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported error message ¿4055 sorter z-axis motor slippage detected¿ error on the aia-2000 analyzer.The customer heard an audible noise and found several test cups inside the analyzer.The customer also removed the top cover and found the pick up arm hitting the back of the tip drawer.In addition, the customer found a metal piece hanging down, and unsure if it was broken or became loose.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event which resulted in a delay reporting of patient samples for progesterone (prog iii).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) was at the customer¿s site to address the reported event.Fse confirmed the complaint by reviewing the error logs and performing all-set-home procedure.During observation, the sorter was found to crash while descending to the next level.The fse inspected the protective plate covering the circuit board and a loose screw holding the plate was identified.The screw was tightened, which prevented further sorter crashes.Fse validated the analyzer informing the customer to perform quality control run without error and within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.Aia-2000 operator's manual on the appendix 4: error messages: (4055) sorter z-axis motor slippage detected cause: the each-limit sensor detected slippage after sorter z-axis movement.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to a loose screw on the protective plate covering the circuit board.

• Brand Name: AIA-2000
• 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: jorge porras ; 2-2-1 yaesu; chuo-ku, tokyo 10400-28 ; JA 1040028 ; 6506368314
• MDR Report Key: 24961052
• Report Number: 3004529019-2026-00052
• Device Sequence Number: 10581029
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/22/2026

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
• Device Catalogue Number: 022100
• 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: 04/02/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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