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	08/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed the reported issue by reviewing the error log.The customer stated a rack was crooked in the sample loader when the error occurred.The fse inspected the x1 step feed position flag and noticed that it was approximately 45 degrees out of alignment.In addition, the sample loader that had some residue.It was determined that the likely cause was a rack jammed in the x1 belt, causing the step feed position flag to slip.The rack was not loaded correctly, or the rack slipped out of position from the residue spot, causing it to twist.The fse was unable to determine the root cause of the reported error.The fse cleaned the sample loader and repositioned the x1 step feed flag.The resolution was verified by running quality control with results within acceptable range and no issues.No further action required by field service.The aia-2000 analyzer is operating as expected.A 13 month retrospective review revealed six (6) occurrences of complaints related to the sample loader rack x1-step feed failure message, however an assessment of the data determined the root causes to vary from a mechanical problem, material problem, operational problem, or a failure to align.Although the failure mode was consistently contributed to failure to align, the documented contributing causes were not uniform.No patient harm was noted, and the data does not indicate a systemic issue.No further escalation is necessary.The aia-2000 analyzer operators manual in appendix 4: error messages states the following: "[2250]" sample loader rack x1-step feed failure.Cause: the pitch sensor did not activate during step feed (x1) operation.Solution: check the sample rack path for obstacles.If this error occurs frequently, contact tosoh service center or local representatives.The most probable cause of the reported event was unable to be determined.
Event or Problem Description
A customer reported "2250 sample loader rack x1-step feed failure" error on the aia-2000 analyzer.The issue occurred after a rack jam.The customer removed the rack and performed an all-set-home, but the error persists.A technical support specialist instructed the customer to power off, restart and check for any spills or debris in loader area.After rebooting, the error reoccurred when loading a rack.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 progesterone iii (prog iii).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 ; +1(650)636-8314
• MDR Report Key: 50488478
• Report Number: 3004529019-2026-00119
• Device Sequence Number: 21360384
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/27/2026

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: 08/05/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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