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

Model Number	AIA-2000LA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) conducted a site visit and confirmed the reported issue by review of the error log.The fse also identified the uninterrupted power supply (ups) beeping with red stop sign indication.The fse measured the voltage on the pib sensor so80 x axis home sensor for cup transfer.The fse then powered off and on the ups with no luck.The fse resoldered three (3) wires to the pib sensor, pushed in wires on connector, and adjusted the x, y, and z axis on the cup transfer.The fse validated the analyzer by running a "get cup macro" action, and running controls with results within acceptable range and no errors recurring.The fse also ordered a replacement ups and returned at a later date for replacement.The aia-2000 analyzer is operating as expected.No further action required by field service.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number: (b)(6).There were no similar complaints found during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: [4153] x-axis cup transfer x-axis home overrun cause: the home sensor activated improperly after x-axis transfer x axis movement.If this occurs, the current measurement result will be flagged (mf flag) and new measurements will be suspended.Solution: contact tosoh service center or local representatives.The most probable cause of the reported issue was due to a loose electrical connection problem with the wires to the pib board, cause traced to component failure.
Event or Problem Description
A customer reported 4153 (2000 only) x-axis cup transfer x-axis home overrun error on the aia-2000 analyzer.The customer checked for obstructions within the analyzer as well as looked in the test cup area for any dropped cups and found none.The customer then powered down and restarted the analyzer and performed and all set home.The error recurred.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 beta human chorionic gonadotropin (bhcg).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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 ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 23375720
• Report Number: 3004529019-2025-00043
• Device Sequence Number: 15669347
• Product Code: KHO
• UDI-Device Identifier: 04560189284623
• UDI-Public: 04560189284623
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/23/2025

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-2000LA
• Device Catalogue Number: 022101
• 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: 10/03/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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