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	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was at the customer¿s site to address the reported event.Fse confirmed the complaint by observing liquid present in the leak detection well (s172).The fse dried the well, cleaned it with deionized (di) water, and ensured the well sensor was thoroughly dried.The well was cleaned and restored to proper condition.The fse also verified that the bf wash probe was functioning and washing properly.The fse validated the analyzer by successfully performing daily check, 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 retrospective review revealed five (5) occurrences of complaints related to "3004 liquid leak detected" on the aia-900 analyzer.However, data assessment determined reported events were mostly due to a maintenance problem, loose connection, leakage/seal problem, no flow and a dust/dirt problem.All causes of the reported errors were corrected prior to reporting patient results.There is no indication of a systemic issue and there is no impact to patient safety.The aia-900 operator's manual under section 12 - flags and error messages states the following: (3004) liquid leak detected.Cause: the drain sensor s172 detected liquid.In this case, measurement will be paused.Action: please contact tosoh local representatives.If there is no liquid leakage, check s172.The most probable cause of the reported event was due to liquid present in the leak detection well (s172).
Event or Problem Description
A customer reported error message¿ 3004 liquid leak detected¿ on the aia-900 analyzer.The customer visually inspected the bf probe area and identified excess liquid and one of the wells was not draining properly.The technical support specialist (tss) instructed the customer to power off the analyzer.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event which resulted in a delay 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 ; 2-2-1 yaesu; chuo-ku, tokyo 10400-28 ; JA 1040028 ; 6506368314
• MDR Report Key: 25194663
• Report Number: 3004529019-2026-00066
• Device Sequence Number: 13359188
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/15/2026

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: 0022930
• 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: 04/20/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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