MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number	AIA-900
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) contacted the customer by phone and verbally confirmed the reported issue.The fse instructed the customer to remove the top, blue cover to the analyzer.The fse then had the customer inspect the cup transfer waste chute, and the customer identified a test cup was lodged sideways on top of the chute creating an obstruction.The fse had the customer remove the lodged test cup, and replace the top blue cover back in position.The fse then instructed the customer to validate the analyzer by powering on the analyzer and perform an "all set home" action with no errors recurring.No further action required by field service.The aia-900 analyzer is operating as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for failure mode "4153 c.Trans-z home overrun".There were twenty-five (25) similar complaints found during the searched period, including this one.The aia-900 operators manual under section 12: flags and error messages states the following: [4153] c.Trans-z home overrun cause: the home sensor s062, which is not supposed to be activated after the cup transfer z-axis moves, was activated.No further operation will take place.A mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s062 and also check to see the cause of slipping, and so on, that occurs when pm061 moves to the limit side.The most probable cause was due to an obstruction within the cup transfer waste chute.
Event or Problem Description
A customer reported 4153 c.Trans-z home overrun error on the aia-900 analyzer.Technical support specialist (tss) instructed the customer to power off the analyzer, ensure the waste bin and waste chute were free of debris, then restart the analyzer and perform an "all set home" action.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) and 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-900
• 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: 24318774
• Report Number: 3004529019-2026-00015
• Device Sequence Number: 17359168
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 02/11/2026

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-900
• Device Catalogue Number: 022930
• 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: 02/02/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2017
• 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