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 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.A field service engineer (fse) was at the customer's site to further investigate.Fse could not duplicate reported issue since all qc results were in acceptable ranges.Fse noticed a few intermittent dl flags on results and decided to clean the detector and replace the 3-way substrate valve proactively.Fse performed test runs and quality control run without any errors and within acceptable range.No further action required by field service.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)(4).There were no other similar complaints found during the searched period.The st aia-pack ca 19-9, analyte application manual states the following: limitations of the procedure.St aia-pack ca 19-9 should not be used as a screening test.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 ca 19-9, the highest concentration of ca 19-9 measurable without dilution is 400 u/ml, and the lowest measurable concentration is 1.0 u/ml (assay sensitivity).Although the approximate value of the highest calibrator is approximately 400 u/ml, the exact concentration may be slightly different depending upon the lot.The assay specification, assay range high, should be defined as the upper limit of the assay range, 400 u/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.A ca 19-9 result below the upper reference limit of normal does not indicate the absence of malignancy because patients with histopathologic evidence of pancreatic cancer may have ca 19-9 assay values within the range of normal individuals.Patients who do not secrete blood group lewis antigen do not produce ca 19-9.Conversely, a ca 19-9 assay value exceeding the upper limit reference limit of normal does not necessarily indicate the presence of pancreatic malignancy since a small percentage of healthy individuals and individuals with non-malignant conditions as well as malignancy in other locations than the pancreas may have elevations in ca 19-9 assay results.A ca 19-9 assay value should not be interpreted as absolute evidence for the presence or absence of malignant disease of the pancreas.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.The aia-900 operator's manual, section 12: flags and error messages states the following: dl flag.A fault occurred in the detector or the substrate feed line.Print and display (rate value) : outputs the measurement values.Print and display (concentration value) : becomes blank.Rs232c output (concentration value) : conforms to the setting that is applicable to the case where no concentration is set in the host.Rs232c output (flag) : a.The most probable cause of the reported event is unknown, could not reproduce reported event.

Event Description

A customer reported discrepant results when running patient samples for ca 19.9 on the aia-900 analyzer.The patient result was 5.5u/ml, which does not appear to be clinically correct.The patient's oncologist requested a rerun of the patient's sample; sample rerun result was 1430u/ml.All quality control (qc) runs were within range both prior to first run and after the second patient sample run.Technical support specialist (tss) reviewed the customer's sample preparation processing and noted that the customer draws the patient sample in an sst and spins it down for 10 minutes then pours the serum off into a transfer tube prior to running the sample.The customer states there were no errors that occurred during the processing of this patient sample and no fibrin was noted in the sample.Tss instructed the customer to run the patient sample for the 3rd time; 3rd run result was 1507u/ml.No further discrepant patient results were reported on this ca19.9 assay.A field service engineer was dispatched for investigation reported event.There was no indication of any patient intervention or adverse health consequences due to the reported event.

• 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
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9930634
• MDR Text Key: 261063341
• Report Number: 8031673-2020-00100
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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