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	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported "all quality control (qc) is out of linearity" on the aia-360 analyzer.The customer stated the daily check passed, installed a new wash solution, diluent, and substrate; all were equilibrated overnight.There were no flags or analyzer error codes other than linearity is out for all qc.The analyzer power was reset, but issue persists.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 iii (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) was dispatched to address the reported event.The fse confirmed the issue by reviewing printouts of the quality control (qc) results.The fse inspected the sample nozzle, performed level sense checks and cleared a clog from the sample nozzle.The fse verified the resolution by successfully running qc within acceptable ranges.No further action required by the fse.The aia-360 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 failure mode "qc out of linearity for prog iii" on the aia-360 analyzer.There were two similar complaints identified during the search period, including this case.The analyte application manual for progesterone iii (prog iii) states the following: evaluation of results quality control in order to monitor and evaluate the precision of the analytical performance, it is recommended that commercially available control samples shall be assayed according to the local regulations.The minimum recommendations for the frequency of running internal control material are: after calibration, two levels of the internal control are run in order to accept the calibration curve.The two levels of controls are also repeated when certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, maintenance of the wash probe, or detector lamp adjustment or change).After daily maintenance, at least two levels of the control shall be run in order to verify the overall performance of the tosoh aia system analyzers.If one or more control value(s) is out of the acceptable range, it is necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the strict regulatory agency under which the laboratory operates.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 progiii, the highest measurable concentration of progesterone in specimens without dilution is 40 ng/ml, and the lowest measurable concentration in specimens is 0.1 ng/ml (assay sensitivity).Although the approximate value of the highest calibrator is 45 ng/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, 40 ng/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.Samples from patients who had an injection of fluorescein, which is used in fluorescein fundus angiography, may cause falsely elevated results 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.Heterophile antibodies are known to interfere in assays of this type.St aia-pack progiii has been designed to minimize the effects of heterophile antibodies, but interference from high titers cannot be ruled out.The most probable cause of the reported issue was due to a clogged sample nozzle, cause traced to maintenance.

• 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 ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 24725763
• Report Number: 3004529019-2026-00038
• Device Sequence Number: 10265556
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 03/29/2026

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: 03/09/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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