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

Model Number	AIA-2000ST
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed software database corruption by attempting to reset the database.The fse reinstalled the aia-2000 software and instructed the customer to calibrate all tests and run quality control (qc).The resolution was verified by recalibrating all tests, verifying qc and transmitting to the laboratory information system (lis) without issues.No further action required by field service.The aia-2000 analyzer is operating as expected.A 13 month retrospective review revealed twenty (20) occurrences of complaints related to "software problem" across seven (7) aia-2000 analyzers.However further data assessment did not reveal a correlation between the reported events.The analyzers with repeat failure mode, also had no similar cause.The events revealed the various failures were triggered by communication problem, power fluctuation, software problem, configuration issue, intermittent continuity, electrical problem, data storage or loss of data and operational error.All causes of the reported errors were corrected prior to reporting patient results.There is no indication of a systemic issue and there is no impact to patient safety.The most probable cause of the reported event was due to corrupted aia-2000 software, cause traced to component failure.
Event or Problem Description
A customer reported that the computer shut down in the middle of a run on the aia-2000 analyzer.Following the computer restart, samples that were in process at the time of the shutdown appeared in the software with reported results, despite the run not having been completed.The customer stated that these incorrect results remained on the results list despite clearing the specimen database and restarting both the software and computer.The customer then loaded three new samples and during the run, the software prompted for a dilution although no dilution was required.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: janefrances ajiduah ; 2-2-1 yaesu; chuo-ku, tokyo 10400-28 ; JA 1040028 ; 6506368314
• MDR Report Key: 25385961
• Report Number: 3004529019-2026-00072
• Device Sequence Number: 18809441
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• 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): 06/03/2026

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
• Device Lot Number: N/A
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2018
• 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