MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. (OHIO) AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number	AIA-900 REFURBISHED
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported "4276 incubator positioning error and noise" on the aia-900 analyzer.The issue occurred at the start of a calibration run and the customer reset the power, but the issue remains.An all-set-home was performed and failed.In addition, a noise was heard while attempting to perform the all-set-home.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) and 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) was dispatched to address the reported event.The fse confirmed the issue with the customer over the phone.The fse instructed the customer to move the incubator manually and was informed that it was hard to move initially but was able to move it.The fse instructed the customer to remove the incubator cover.After removal of the cover, the customer identified a dropped test cup.After removing the dropped test cup and cleaning the cup transfer arm the analyzer was functioning properly.The customer verified the analyzer was operating properly.No further action required by the fse.The aia-900 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for failure mode "4276 incubator positioning error" on the aia-900 analyzer from (b)(6) 2025 through aware date march 17, 2026.There were two similar complaints identified during the search period, including this case.A 13-month complaint history review and service history review for similar complaints was performed for failure mode "noise during all-set-home" on the aia-900 analyzer from (b)(6) 2025 through aware date march 17, 2026.There were three 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: [4276] incubator positioning error cause: the home sensor s120, which is supposed to detect the incubator when it reaches the target position, failed to be activated.Measurement will be interrupted.Action: please contact tosoh local representatives.Check s120 and pm120 for a possible malfunction.The most probable cause of the reported event was due to a dropped test cup, the cause of the dropped test cup could not be established.
Additional Manufacturer Narrative
A review of the device history record (dhr) was conducted for serial number (b)(6) which confirmed that there were no nonconformance, failure, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.Corrected section g contact address.

• Brand Name: AIA-900
• Common Device Name: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer Contact: jorge porras ; shiba-koen first building; 2-2-1 yaesu; chuo-ku, tokyo 10400-28 ; JA 1040028 ; 6506368314
• MDR Report Key: 24860932
• Report Number: 3005529799-2026-00002
• Device Sequence Number: 9271676
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/17/2026

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 REFURBISHED
• Device Catalogue Number: 022930R
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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