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

Model Number	AIA-2000LA
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
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 reviewing the checklist chart.While troubleshooting, the fse visually observed the substrate syringe and indicated a wear problem.The fse also observed the 3-way solenoid valve and identified a leakage issue.The fse replaced the substrate syringe, 3-way solenoid valve, and resolved the complaint.Fse repaired and validated the analyzer by confirming all temperatures, running the daily check, and successfully performed quality control run without error and within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.A 13-month complaint history review for similar complaints was performed for bh substrate background high flag on the aia-2000 analyzer from 04feb2025 through aware date of 04mar2026.There were two similar complaints identified during the search period, including this case.Aia-2000 operator's manual on the appendix 3: flag messages: (bh flag) bh substrate background high descriptions: indicates the substrate background high (bh).Change to new substrate and reschedule assay operation.The most probable cause of the reported event was due to wear problem with the substrate syringe and leak from the 3-way solenoid valve.
Event or Problem Description
A customer reported ¿bh substrate background high flag¿ due to high substrate values during the daily check on the aia-2000 analyzer.One bottle of substrate increased four times, and the second substrate bottle increased ten times the values and failed the daily check.The technical support specialist (tss) instructed the customer to perform a weekly substrate maintenance with nitric acid and open another substrate from another box.The issue persists 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).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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: 24671262
• Report Number: 3004529019-2026-00032
• Device Sequence Number: 10102133
• 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
• Report Date (Section B): 03/23/2026

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-2000LA
• Device Catalogue Number: 022101
• Device Lot Number: N/A
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2017
• 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