MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number	AIA-900
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	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Technical support specialist (tss) followed up with the customer on the reported event and the customer stated they ran the recommended precision.The customer provided the precision study results for review, and tss confirmed the results were as expected, with results as "l (low)" and one result was 0.06ng/m.No further action required by technical support specialist.The aia-900 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 "prostate specific antigen (psa) discrepancy" on the aia-900 analyzer.There were five (5) similar complaints found during the searched period, which includes this event.The analyte application manual for prostate specific antigen (psa) states the following: specimen collection and handling serum or heparinized plasma is required for the assay.Edta and citrated plasma should not be used.No special patient preparation is necessary.When using serum, a venous blood sample is collected aseptically without additives.Store at 18 - 25 °c until a clot has formed (usually 15 - 45 minutes), then centrifuge to obtain the serum specimen for assay.To use heparinized plasma, a venous blood sample is collected aseptically with the designated additive.Centrifuge and separate plasma from the packed cells as soon as possible.Because there is controversy as to whether any prostatic manipulation affects the psa results, samples should be drawn before any prostatic procedures such as dre, prostatic massage and trus are performed.Samples may be stored at 2 - 8 °c for up to 24 hours prior to analysis.If the analysis cannot be done within 24 hours, the sample should be stored frozen at -20 °c or below for up to 60 days.Repeated freeze-thaw cycles should be avoided.Turbid serum samples or samples containing particulate matter should be centrifuged prior to testing.Prior to assay, slowly bring frozen samples to room temperature (18 - 25 c) and mix gently.The sample required for analysis is 20 l 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 be assayed daily.The minimum recommendations for the frequency of running internal control material are: after calibration, two levels of controls are run in order to accept the calibration curve.The two levels of controls are also repeated after calibration 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 should be run in order to verify the overall performance of the tosoh aia system analyzers.If one or more control sample value(s) is out of the acceptable range, it will be necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the 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 pa, the highest concentration of prostate specific antigen measurable without dilution is 100 ng/ml, and the lowest measurable concentration is 0.05 ng/ml (assay sensitivity).Although the approximate value of the highest calibrator is 50 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, 100 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.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 or decreased psa values.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.Expected values each laboratory should determine a reference interval corresponding to the characteristics of the population being tested.As with all diagnostic procedures, clinical results must be interpreted with regard to concomitant medications administered to the patient.Results from the st aia-pack pa assay should not be interpreted as being definitive for the presence or absence of prostate cancer.Patients with levels of psa within the reference interval found in apparently healthy subjects may have prostate cancer; patients with levels exceeding those in the reference interval may be prostate cancer free.Results from the st aia-pack pa should be interpreted in the light of other clinical findings and diagnostic procedures such as dre.Biopsy of the prostate is currently the medically accepted standard used to confirm the presence/absence of prostate cancer.The most probable cause of the reported event could not be established.
Event or Problem Description
A customer reported potential patient result discrepancy for prostate specific antigen (psa) on the aia-900 analyzer.The customer stated the patient usually has a result of 0.04ng/m (assay range 0.05ng/m to 100.0ng/m), however this result was slightly elevated to 0.06 and was questioned by the patient physician.Technical support specialist (tss) followed up with the customer and provided a copy of the analyte applicate manual (aam) and explained to the customer that the lower detection limit is 0.05ng/m with a sample volume of 20ul.If there is a potential pipetting issue, that could create a shift in the patient result.Tss suggested the customer perform a precision study using a sample at the low end, however, tss noted it was very possible the customer would get results of "l (low)" or "results on the low end of the range".Tss also pointed out to the customer, that per the aam, it is recommended to test psa in conjunction with dre (digital rectal examination) in detecting prostate cancer.There was no indication of any patient intervention or adverse health consequences due to the reported event.

• Brand Name: AIA-900
• 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: 24477160
• Report Number: 3004529019-2026-00021
• Device Sequence Number: 9360758
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 02/27/2026

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-900
• Device Catalogue Number: 022930
• 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: 02/03/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2020
• 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