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

Model Number	AIA-2000ST
Medical Device Problem Codes	Mechanical Problem (1384); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported error messages ¿3036 detector temperature lower limit error, 3039 substrate temperature lower limit error, and error on the aia-2000 analyzer stating aia-2000 controller started without analyzer and com port already open" (host communication error) on the aia-2000 analyzer.The customer restarted the analyzer multiple times and confirmed all cables were secure, errors recurred.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 progesterone (prog iii).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) contacted the customer by phone and confirmed the reported issue.The customer stated the only issue they were now experiencing was the host communication error.The "3036 detector temperature lower limit error and 3039 substrate temperature lower limit error" was no longer occurring.The fse requested the customer provide details of the host communication issue they were experiencing, and the customer stated the analyzer was not communicating with the laboratory information system (lis).The fse instructed the customer to verify settings and ensure the keyspan adapter was plugged in, the issue recurred.The fse then instructed the customer to reset the usb power hub where the keyspan adapter plugs into due to the keyspan adapter being used to plug into the lis via an ethernet connection, and the issue resolved.The customer validated the analyzer by running samples with no errors recurring.No further action required by field service.The aia-2000 analyzer is operating as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for failure mode "3036 detector temperature lower limit error " on he aia-2000 analyzer.There were three (3) similar complaints found during the searched period, including this one.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for failure mode "3039 substrate temperature lower limit error " on the aia-2000 analyzer.There were two (2) similar complaints found during the searched period, including this one.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for failure mode "host communication error" on the aia-2000 analyzer.There were four (4) similar complaints found during the searched period, including this one.The aia-2000 analyzer operator's manual under appendix 4: error messages, states the following: [3036] detector temperature lower limit error cause : the detector temperature decreased to below the lower limit (standard: 30).The current measurement will be flagged (io flag) and new measurements will be suspended.Solution : reset the main power.Contact tosoh service center or local representatives.[3039] substrate temperature lower limit error cause : the substrate temperature decreased to below the lower limit (standard: 30).The current measurement will be flagged (io flag) and new measurements will be suspended.Solution : reset the main power.Contact tosoh service center or local representatives.The most probable cause was due to a software issue with the usb power hub where the keyspan adapter plugs into, component failure.

• 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: 24527079
• Report Number: 3004529019-2026-00024
• Device Sequence Number: 8439546
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/05/2026

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: 022100
• 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: 02/11/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2022
• 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