MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number	AIA-2000 LA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported ¿2233 b/f probe 3 overflow sensor failure, 2234 b/f probe 4 overflow sensor failure, 2235 b/f probe 1 suction failure and wu b/f separation failure" during daily checks and patient processing on the aia-2000 analyzer.A technical support specialist instructed the customer to verify the probes were not switched and tips were secure; no issues were observed.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 human chorionic gonadotropin (hcg).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 issues by reviewing the error log.The fse visually inspected b/f probe 1, probe 3, and probe 4; noticed excess waste buildup in the tubes leading to the waste valves and cleaned it.The fse verified the resolution by successfully performing a daily check and quality control (qc) without error and within acceptable range.The customer called back the following day and error 2235 b/f probe 1 suction failure returned.An fse was dispatched again to address the reported event.The fse confirmed the issues by reviewing the error log.The fse primed the b/f wash probes and replaced the 2-way solenoid valve for b/f wash probe #1.In addition, the fse cleared the clogged waste tubing for wash probe #1 and replaced wash probe #1.The resolution was verified by running controls without errors.No further action required by field service.The aia-2000 analyzer is functioning as expected.A 13-month complaint and service history review through the aware date of event for similar complaints was performed for serial number (b)(6).There were no similar complaints identified during the search period.The aia-2000 operator's manual under appendix 4: error messages states the following: [2233] b/f probe 3 overflow sensor failure cause: the overflow sensor is detecting liquid continuously.Solution: clean b/f probe 3.(see chapter 9, "maintenance") if retry fails, contact tosoh service center or local representatives.[2234] b/f probe 4 overflow sensor failure.Cause: the overflow sensor is detecting liquid continuously.Solution: clean b/f probe 4.(see chapter 9, "maintenance") if retry fails, contact tosoh service center or local representatives.[2235] b/f probe 1 suction failure.Cause: the overflow sensor detected liquid after washer suction action was completed.The measurement result will be flagged (wu flag).Solution: clean b/f probe 1.(see chapter 9, "maintenance") if retry fails, contact tosoh service center or local representatives.Wu flag: cause: indicates b/f separation failure.Solution: perform maintenance of b/f wash probes by referring to ¿chapter 9: maintenance.¿ if this fails to resolve the problem, contact tosoh service center or local representatives.The most probable cause of the reported event was due to clogged waste tubing, failures of wash probe 1 and 2-way solenoid valve.
Additional Manufacturer Narrative
The 2way solenoid valve and washing probe assembly were returned to the tosoh warehouse per the tracking information provided, however the part(s) could not be located by the instrument service center (isc) personnel.Due to the returned part(s) being lost in transit, a product evaluation could not be completed.

• Brand Name: AIA-2000
• 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: 22771974
• Report Number: 3004529019-2025-00006
• Device Sequence Number: 9574698
• Product Code: KHO
• UDI-Device Identifier: 04560189284623
• UDI-Public: 04560189284623
• 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,Followup
• Report Date (Section B): 10/07/2025

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-2000 LA
• Device Catalogue Number: 022101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2016
• 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