MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-360; FLUOROMETER, FOR CLINICAL USE

Model Number	AIA-360 IMMUNOASSAY ANALYZER
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	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: previously documented: a 13-month complaint and service history review for similar complaints was performed for "luteinizing hormone test cup lot # f513991".There were no similar complaints identified during the search period.Correction: a 13-month complaint and service history review for similar complaints was performed for "luteinizing hormone test cup lot # f513991".There were two similar complaints identified during the search period, including this case.
Additional Manufacturer Narrative
A field service engineer (fse) was dispatched to address the reported event.The fse confirmed the issue by reviewing the aab proficiency testing results.The fse checked all temperatures and they were in range.The fse adjusted the wash probe closer to the bottom of the test cup.After running quality control (qc), the results were still at the low end of the bio-rad range.The fse calibrated a new test cup lot of luteinizing hormone (lh ii) and qc was closer to the mean on two levels.The fse verified the resolution by running qc and results were close to the mean.No further action required by field service.The aia-360 analyzer is functioning as expected.A 13-month complaint and service history review for similar complaints was performed for "luteinizing hormone test cup lot # f513991".There were no similar complaints identified during the search period.The analyte applicate manual for luteinizing hormone (lh ii) states the following: limitations of the procedure for diagnostic purposes, the results obtained from this assay should be used in conjunction with other data (e.G., symptoms, results of other tests, clinical impressions, therapy, etc.).Using st aia-pack lh ii, the highest concentration of luteinizing hormone measurable without dilution is approximately 200 miu/ml, and the lowest measurable concentration is 0.2 miu/ml (assay sensitivity).Although the approximate value of the highest calibrator is 200 miu/ml, the exact concentration may be slightly different.The assay specification, assay range high, should be defined as the upper limit of the assay range, 200 miu/ml.Although hemolysis has an insignificant effect on the assay, hemolyzed samples may indicate mistreatment of a specimen prior to assay and results should be interpreted with caution.Lipemia has an insignificant effect on the assay except in the case of gross lipemia where spatial interference may occur.Specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (hama).Such specimens may show falsely elevated values when tested for luteinizing hormone.Certain medications may interfere with assay performance.Specimens from patients taking medicines and/or medical treatment may show erroneous results.All results should be interpreted with respect to the clinical picture of the patient.The most probable cause of the reported event was due to a degradation problem of the test cup lot, cause traced to component failure.
Event or Problem Description
A customer reported all five levels of american association of bioanalysts-medical laboratory evaluation (aab-mle) proficiency testing failed in september 2025 and february 2026 for luteinizing hormone (lh ii) on the aia-360 analyzer.The failed proficiency testing from september 2025 was not reported to tosoh at the time of occurrence.The tosoh quality assurance (qa) laboratory passed all aab-mle m3 (b)(6) 2025 and aab-mle m1 (b)(6) 2026 proficiency testing.The customer stated quality control (qc) was within range, all other analytes passed and the shipment was received with no issues noted.A technical support specialist offered to send multi analyte control (mac) controls, but customer requested service as this is the second time they have failed the proficiency test for lh ii.Field service was dispatched for further investigation.There was no indication of any patient intervention or adverse health consequences due to the reported event.

• Brand Name: AIA-360
• 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: 24921303
• Report Number: 3004529019-2026-00049
• Device Sequence Number: 18453702
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/22/2026

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-360 IMMUNOASSAY ANALYZER
• Device Catalogue Number: 019945
• 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: 03/26/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/19/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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