MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: field service engineering (fse) visited the customer to address the reported event.During the evaluation, fse confirmed the complaint by the customer running the sample again.Fse was not able to reproduce the issue.It was suspected that there was foil possibly from the beltline decapper blocking sample nozzle.Fse observed error 4224 in the error log that indicated there was interference in the nozzle z-axis of the main arm.Fse suspected that another possible cause was the main arm to the tube in the x-axis was out of alignment.Fse performed an adjustment to the specimen nozzle in the x-axis at the belt line.Fse then ran precision on the psa and quality controls were run with acceptable results.The instrument was operating as expected.There was no further action required by fse.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from the 05-jan-2018 through aware date of (b)(4) 2019.There were three similar complaints , including this event, identified during the searched period.The aia-2000 operator's manual under chapter 1 general precautions for use states the following: effective system management: producing consistently accurate assay results requires managing both the aia-2000 and the various reagent supplies according to a set of designated management standards.The performance of the analyzer and reagents can be verified to meet these performance standards by conducting control measurement operations at regular intervals.The aia-2000 is equipped with self-diagnosis routines that display error messages whenever faults are detected.Corrective steps can be taken in the event of errors by referring to the appropriate section in this manual.Under chapter 9 maintenance states the following: six - to - 12 month maintenance: to ensure stable operation of the aia-2000 system, it is important to regularly lubricate the moving parts with grease, perform position accuracy adjustments and clean the various system parts at regular intervals.It is recommended that these maintenance tasks are performed at regular intervals by service personnel.Appendix 4 error messages states the following: [4224] interference of dispensing nozzle z-axis of main arm: cause : there is a possibility that the dispensing nozzle was interfered with an obstacle such as cap of primary tube.The measurement result will be flagged with the ss flag.Or a command or adjustment value (p05, 191-210) was given for movement beyond the maximum movable distance of the main arm z-axis in the maintenance operation.Solution : remove an obstacle such as cap of primary tube, if any.The st aia-pack prostate antigen (psa) assay application manual (aam) 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.All results should be interpreted with respect to the clinical picture of the patient.For a more complete understanding of the limitations of this procedure, please refer to the specimen collection and handling, warnings and precautions, storage and stability, and procedural notes sections in this insert sheet.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 following data was collected using the aia-pack pa.The st aia-pack pa demonstrates equivalent performance.(see comparative analysis.) the most probable cause of the issue was the sample nozzle in the x-axis at the belt line needed to be adjusted.

Event Description

A customer reported that a prostate-specific antigen (psa) patient sample was initially 0.05 ng/ml and upon repeat, the result was 5.3 ng/ml on the aia-2000 instrument.The customer stated that there were no issues with the sample on inspection.The customer had another sample the day before that resulted less than 0.05 ng/ml and when it was repeated, the result was 8.36 ng/ml (refer to mfr report #: 8031673-2019-00037 and uf/importer report #: (b)(4)).The customer reported that the sample nozzle is cleaned weekly.There was no indication of patient intervention or adverse health consequences due to discrepant prostate-specific antigen (psa) patient results.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: doria esquivel ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368123
• MDR Report Key: 8386408
• MDR Text Key: 138256362
• Report Number: 8031673-2019-00032
• Device Sequence Number: 1
• Product Code: KHO
• 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
• Type of Report: Initial
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000
• Device Catalogue Number: 022101
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2019
• Distributor Facility Aware Date: 02/05/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2019
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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