MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000 LA; 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	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed the reported errors by viewing the error log and seeing the sorter arm fail.The fse checked the x-axis home sensor s020 (pip board) and wire harness pin 2 on connector p11 (p11-2) to connector 13 (cn13) on the sorter board and found that the red 5 volt (5v) wire was broken on the plarail chain harness.The fse replaced the sorter plarail chain assembly.The fse verified the resolution by running macros and quality control run without error and within acceptable ranges.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 cases found during the search period.The aia-2000 operator's manual under appendix 4: error messages states the following: [4033] sorter x-axis home overrun.Cause: the home sensor activated improperly following movement of the sorter x-axis.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.[4063] sorter tip pickup z-axis home overrun cause : the home sensor activated improperly following movement of the z-axis sorter tip pickup.If retry fails, the measurement result will be flagged (mf flag).Solution : contact tosoh service center or local representatives.The most probable cause of the reported event was due to a broken wire on the sorter plarail chain assembly.
Event or Problem Description
A customer reported "4033 sorter x-axis home overrun and 4063 sorter tip pickup z-axis home overrun" errors on the aia-2000 analyzer.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
The sorter plarail chain assembly was returned to tosoh instrument service center (isc) for investigation.A visual inspection was conducted on the part looking for cracks, misalignments, corrosion, and other physical defects and no damage or defects observed.Isc confirmed the 5v red wire was broken indicating component failure of the sorter plarail chain assembly.

• Brand Name: AIA-2000 LA
• 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: 21260889
• Report Number: 3004529019-2025-00685
• Device Sequence Number: 18526314
• 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): 04/02/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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