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

Model Number AIA-900

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2023

Event Type  malfunction  

Event Description

A customer reported inconsistent discrepant results for prostate specific antigen (psa) on the aia-900 analyzer.The customer is intermittently getting psa results that are undetectable and upon retesting, a result will become available.The physicians are questioning the issue.The quality control (qc) was within ranges before running psa samples.A field service engineer (fse) was dispatched to further investigation.There is no indication of any patient intervention or adverse health consequences due to the reported discrepant patient result.

Manufacturer Narrative

A field service engineering (fse) followed up with the customer over the phone to address the reported event.Fse confirmed the complaint while troubleshooting with the customer and suspects a washing problem with the reagents or component parts.The fse provided guidance to the customer, demonstrating how to monitor the wash probes and ensure they were not sticking and springing back to the home position.The customer found wash probe #2 was not springing back properly and the fse instructed the customer to clean the shaft to correct the issue.The customer will run some psa patient samples for the next few days to see if the issue was resolved.Fse followed up with the customer and the psa results have been acceptable since cleaning wash probe #2.No further action required by field service.The customer validated the aia-900 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(6).There were two other similar complaints found during the searched period including this case.The st pa, analyte application manual 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 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.The most probable cause of the reported discrepant prostate specific antigen (psa) results was due to a dirty shaft of wash probe #2.

• Brand Name: AIA-900
• Type of Device: 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: 18008488
• MDR Text Key: 326815023
• Report Number: 3004529019-2023-00446
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1