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

Model Number	AIA-900
Medical Device Problem Codes	Mechanical Problem (1384); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported 4231 reag/tip-x home detect error and audible noise on the aia-900 analyzer.The customer stated the error occurs in the middle of a run.Technical support specialist (tss) instructed the customer to visually inspect the reagent tip tray and reseat it, then perform an all-set home.The customer chose not to troubleshoot and requested service.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 (prog iii).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 verbally confirmed the reported event with the customer.The fse visually inspected the reagent tip assembly and found it would not move due to a broken x sensor.This caused the reagent tup assembly to be stuck.The fse replaced the broken sensor and confirmed the reagent tip assembly is now moving freely with no restrictions.The fse validated the analyzer by running a daily check and quality control (qc) with results within acceptable range and 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 "4231 reag/tip-x home detect error".There were three (3) similar complaints found during the searched period, including this one.The aia-900 analyzer operators manual under section 12: flags and error messages states the following: [4231] reag/tip-x home detect error cause: the home sensor s090 failed to be activated after the reagent loader moved toward the home position.No further operation will take place.Action: remove the impediment or other cause of the error.Check s090 and pm090 for a possible malfunction.The most probable cause of the reported issue was due to a broken x sensor, cause traced to component failure.
Additional Manufacturer Narrative
A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for failure mode "crashing noise".There were three (3) similar complaints found during the searched period, including this one.

• 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: 24679151
• Report Number: 3004529019-2026-00035
• Device Sequence Number: 15884529
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 04/14/2026

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: 03/06/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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