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

Model Number	AIA-2000ST
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
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 error logs and visually observed the sorter stopped in the z-axis position.The fse also observed the sorter z-axis bearings and identified lubrication was needed.Fse lubricated the sorter z-axis bearings, performed cup macro three times and was within specifications.Fse validated the analyzer by successfully performing 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 and service history review for similar complaints was performed for failure mode "4055 sorter z-axis motor slippage detected " for the aia-2000 analyzer from (b)(6) 2025 through aware date 26mar2026.There were two (2) 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 "2070 clogging detected during specimen suction by main arm" for the aia-2000 analyzer from (b)(6) 2025 through aware date 26mar2026 there were nineteen (19) 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" for the aia-2000 analyzer from (b)(6) 2025 through aware date 26mar2026 there were twenty (20) similar complaints identified during the search period, including this case.Escalation review a 13 month retrospective review revealed revealed nineteen (19) occurrences of 2070 clogging detected during specimen suction by main arm" and twenty (20) occurrences of audible noise on the aia-2000 analyzer.Causes usually are associated with mechanical damage, sample processing, mishandling, misalignment, clogging/blockage or wear and tear.Data assessment determined the occurrences were mostly attributed to obstruction of flow/maintenance problem.All causes of the reported event were corrected prior to reporting patient results.Regular analyzer maintenance and following proper procedure will minimize the reported errors.There is no indication of a systemic issue and there is no impact to patient safety.Aia-2000 operator's manual in appendix 4: error messages states the following: (4055) sorter z-axis motor slippage detected cause: the each-limit sensor detected slippage after sorter z-axis movement.Solution: contact tosoh service center or local representatives.(2070) clogging detected during specimen suction by main arm cause: the negative pressure detected after specimen suction exceeded the standard.The specified amount of specimen may not have been obtained because the sampling nozzle was blocked.The measurement result will be flagged (sc flag).Solution: verify that the specimen is free of solid substances (such as fibrin) or that there is sufficient volume of specimen if it is prepared in the primary tube and retry the measurement.If retry fails, contact tosoh service center or local representatives.The most probable cause of the reported event was due to z-axis bearings of the sorter needed lubrication.
Event or Problem Description
A customer reported error message ¿4055 sorter z-axis motor slippage detected and 2070 clogging detected during specimen suction by main arm¿ on the aia-2000 analyzer.The technical support specialist (tss) suggested the customer reboot and perform an all-set-home.While running the analyzer an audible grinding noise was heard, 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).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 ; 2-2-1 yaesu; chuo-ku, tokyo 10400-28 ; JA 1040028 ; 6506368314
• MDR Report Key: 24974602
• Report Number: 3004529019-2026-00053
• Device Sequence Number: 17388151
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/23/2026

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-2000ST
• Device Catalogue Number: 0022100
• 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: 03/26/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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