MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Obstruction of Flow (2423)

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

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer¿s site to address the reported event.Fse confirmed the complaint by reviewing the result printouts and fse did not try to reproduce the errors because the problem was intermittent.Fse suspected the sampling system and wash system.While troubleshooting, fse found a clot of the serum in the sampling nozzle assembly causing the analyzer to aspirate an incorrect volume.Fse manually checked all samples for fibrin clots, re-spin specimens for a prolong period, and cleaned the sampling assembly.Fse resolved the complaint by cleaning the sample nozzle, successfully performed daily check, quality control and ten (10) patient samples runs without errors and within specifications.No further action required by field service.The aia-2000 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 24dec2021 through aware date 24jan2023.There were no similar complaints identified during the search period.A 13-month lot review for prostate specific antigen (psa) lot # c312868 from 24dec2021 through the aware date 24jan2023 was performed for similar complaints.There were no similar complaints identified during the search period.Aia-2000 operator's manual on the appendix 4: error messages: (3003) substrate 2 (right) shortage cause: the level sensor of substrate bottle 2 is not detecting fluid.Measurement is suspended.Solution: replenish the substrate.If the bottle label is incorrectly positioned, ensure it is facing the front so it does not interfere with the sensor.If the substrate level is sufficient, contact tosoh service center or local representatives.(0601) substrate suction switched from substrate bottle 2 (right) to 1 (left) cause: the substrate bottle was switched from 2 to 1 because substrate bottle 2 was exhausted or the measurement has finished.Solution: in case of a substrate shortage, replenish substrate bottles 1 and 2.If the bottle label is incorrectly positioned, ensure it is facing the front so it does not interfere with the sensor.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 results was most likely due clogged sampling nozzle.

Event Description

A customer reported ¿fluctuating discrepant prostate specific antigen (psa) for four(4) patient sample results¿ on the aia-2000 analyzer.The psa results were running high and the customer repeated the test and was low which was expected.The customer ran and repeated other psa samples at the same time and results correlated as expected.The psa test cup lot# c312868 and quality control (qc) was within acceptable range.When switching the substrate bottle from right to left error messages 3003 substrate shortage and 601 substrate suction occurred.Technical support specialist (tss) contacted the customer by phone and the customer stated they have a small amount of samples for retesting all four psa samples.The customer repeated testing and resulted in lower values which was aligned with patient clinicals.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.

• Brand Name: AIA-2000
• 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: 16406196
• MDR Text Key: 310162487
• Report Number: 3004529019-2023-00263
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 04560189284616
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000 ST
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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