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	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported error 4193 (2000 only) y-axis cup transfer z-axis home overrun on the aia-2000 analyzer.The customer confirmed the waste was not full, then attempted to perform an all set home and empty waste cup action, however, neither would complete.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.
Additional Manufacturer Narrative
A field service engineer (fse) conducted a site visit and confirmed the reported issue by visually identifying the y-axis cup picking assembly was stuck at the discard chute.Further visual inspection revealed the discard chute was full of discarded cups as well as contained dried serum.The fse removed the discard chute and lower assembly which allowed proper removal of the excess cups and dried serum.The fse then removed dried serum from the upper part of the analyzer.The fse reconnected the discard chute and lower assembly, then validated the analyzer by running quality control (qc) with results within acceptable range.The fse then confirmed all cups were properly discarding into the waste bin via the waste chute.No further action required by field service.The aia-2000 analyzer is operating as expected.The aia-2000 analyzer operators manual under appendix 4: error messages states the following: "[4193]" y-axis cup transfer z-axis home overrun cause : the home sensor activated improperly after movement of the y-axis cup transfer z-axis.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 was due to maintenance problem of the cup waste chute.

• 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: 50797380
• Report Number: 3004529019-2026-00130
• Device Sequence Number: 10529396
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/16/2026

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: 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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