MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

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

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

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse was not able to reproduce the issue.The fse replaced the specimen dispense syringe and resolved the issue.Instrument validation was performed by quality control (qc).Qc results passed within the published ranges.The aia-900 analyzer returned to operation.The fse returned to the customer site several days after where the customer reported bhcg result on the aia-900 analyzer was <0.5 miu/ml compared to lab core methodology.The fse could not reproduce the issue.The fse verified and adjusted all sample probe tip bottoms, liquid sense, and level detection to resolve the issue.Instrument validation was performed by quality control (qc).Qc results passed within the published ranges.The aia-900 analyzer returned to operation.No further action required by field service.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 23sep2018 to aware date (b)(6) 2019.One other similar complaint was identified during the search period.The st aia-pack st bhcg 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 bhcg, the highest concentration of total beta hcg measurable without dilution is 400 miu/ml, and the lowest measurable concentration is 0.5 miu/ml (assay sensitivity).Although the approximate value of the highest calibrator is 200 miu/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, 400 miu/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 values when tested for total beta hcg.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.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 which corresponds 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.The probable cause of the issue is pending investigation.

Event Description

A customer reported discrepant bhcg results on the aia-900 analyzer.Two patient samples were analyzed.One sample resulted in a low value.The sample was then taken from the freezer and retested a few days later and the result was 84 miu/ml.The second sample had a result of >h which was then diluted at 1:150 and generated a result of 388 miu/ml.The customer then performed a study of the tubes being used in the laboratory.The outcome of the study did not show any discrepant results.The customer sent out all impacted samples to a reference lab for confirmation.A project request was completed on the samples sent to tosoh quality assurance (qa) lab from the customer.All samples correlated with the customer results.Samples analyzed by the customer all had initially low results on the first run and higher results on retest.Tosoh qa lab did not experience these issues with the samples.A field service engineer (fse) was dispatched to address the reported issue.There was no indication of patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

Correction: g4.

Manufacturer Narrative

Device evaluation: the probable cause of the issue is attributed to faulty sample syringe unit.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 9365813
• MDR Text Key: 220569888
• Report Number: 8031673-2019-00465
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• 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: 022930111
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1