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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineering (fse) followed up with the customer over the phone to address the reported event.Fse confirmed the complaint and the customer stated the problem was reproducible when performing prime bf wash under maintenance screen.The fse suspected there was dust on the wash syringe home sensor (s100) and instructed the customer to clean the dust from the sensor.The customer validated the analyzer by successfully performing daily check and quality control run without error and within acceptable range.No further action required by field service.The aia-900 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for 4253 wash-syr home overrun failure from 29dec2024 through aware date of 29jan2026.There were two similar complaints identified during the search period, including this case.The aia-900 operator's manual under section 12 - flags and error messages states the following: (4253) wash-syr home overrun cause: the home sensor s100, which is not supposed to be activated after the wash syringe moves, was activated.A wu flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s100 and also check to see the cause of slipping, and so on, that occurs when pm100 moves to the limit side.The most probable cause of the reported event was due to dust on the wash syringe home sensor.
Event or Problem Description
A customer reported error message ¿4253 wash-syr home overrun¿ causing the run to be aborted on the aia-900 analyzer.The customer completed an all-set-home and primed the wash.The customer also visually inspected the wash probes and replaced the tips.The error reoccurred while running and 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 (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: 24300161
• Report Number: 3004529019-2026-00013
• Device Sequence Number: 9435606
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/09/2026

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: 01/29/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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