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	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported discrepant results for thyroid stimulating hormone (tsh) on the aia-360 analyzer.The customer runs in cups as well as in the tubes but the issue occurs when running both.Quality control (qc) and calibration are within range.The first run the customer received less than low (
Additional Manufacturer Narrative
A field service engineer (fse) confirmed the issue by talking to the customer over the phone.The fse verified that the analyzer was not down and that there was no issue with cardiac troponin i (ctnl 2).The customer stated that the first sample of thyroid stimulating hormone (tsh) was flagged as low but was acceptable the second time it was run.The fse told the customer that if there was a bubble on top of the serum it would cause the reported issue.The customer stated that they did not believe there was a bubble.The fse instructed the customer to rerun the same patient sample multiple times and run a precision.The customer was able to run available samples, seven (7) additional times with expected results.The customer verified that the analyzer is functioning properly.No further action required by field service.The aia-360 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for "low discrepant results for thyroid stimulating hormone" on the aia-360 analyzer through the aware date.There were two similar complaints identified during the search period, including this case.The analyte application manual for thyroid stimulating hormone (tsh) 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 tsh, the highest concentration of thyroid stimulating hormone measurable without dilution is approximately 100 miu/ml, and the lowest measurable concentration is 0.03 miu/ml (assay sensitivity).Although the approximate value of the highest calibrator is 100 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, 100 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 thyroid stimulating 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 issue could not be determined, however, a bubble on top of the serum could cause the reported issue.

• 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: 25021611
• Report Number: 3004529019-2026-00055
• Device Sequence Number: 10332484
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 04/28/2026

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
• 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: 03/31/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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