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 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineer (fse) was at the customer's site to address the reported event.Fse confirmed discrepancies in results from the past reruns but could not reproduce the problem.Fse resolved the problem by replacing the sampling syringe unit and washer 3-way valves.No further action required by field service.The aia-900 instrument 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 similar complaints identified during the search period.The st aia-pack estradiol (e2) analyte application manual states the following: specimen collection and handling serum or heparinized plasma is required for the assay.Edta and citrated plasma should not be used.No special patient preparation is necessary.When using serum, a venous blood sample is collected aseptically without additives.Store at 18 - 25 °c until a clot has formed (usually 15 - 45 minutes), then centrifuge to obtain the serum specimen for assay.To use heparinized plasma, a venous blood sample is collected aseptically with the designated additive.Centrifuge and separate plasma from the packed cells as soon as possible samples may be stored at 2 - 8°c for up to 24 hours prior to analysis.If the analysis cannot be done within 24 hours, the sample should be stored frozen at -20 °c or below for up to 60 days.Repeated freeze-thaw cycles should be avoided.Turbid serum samples or samples containing particulate matter should be centrifuged prior to testing.Prior to assay, slowly bring frozen samples to room temperature (18 - 25 °c) and mix gently.The sample required for analysis is 75 ul.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 e2, the highest concentration of estradiol measurable without dilution is approximately 3000 pg/ml, and the lowest measurable concentration is 25 pg/ml (assay sensitivity).Although the approximate value of the highest calibrator is 3250 pg/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, 3000 pg/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 with hyperbilirubinemia may yield falsely elevated results.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 aia-900 operator's manual under safety precautions, states: operate only in accordance with the procedures described in this manual - attempts to operate the aia-900 using procedures not prescribed in this manual may adversely affect the integrity of assay results and cause system malfunctions.Under section 1 basic precautions: reagent handling - for reagents required lot management, the aia-900 recognizes their lot numbers.Since mixing such reagents from different lots makes the lot management impossible, reagents must be handled correctly according to their instructions for use.The most probable cause of the reported event was due to faulty sampling syringe unit and washer 3-way valve.

Event Description

A customer reported high discrepant estradiol (e2) patient results on the aia-900 instrument.The customer confirmed quality control (qc) was within acceptable range.The customer ran three patient samples using sst tubes and results were as follows: (b)(6).All results were higher than expected.The third patient sample rerun was performed with a dilution on same day, therefore the customer expected result to be >3000pg/ml.The customer repeated the last patient run the next day with 2x dilution, result was 2457.9pg/ml, 5x dilution, result was 2177.2pg/ml and 10x dilution, result was 2069.6pg/ml.Technical support specialist (tss) was contacted and noted that all results were high, and the problem could be attributed to the customer's specimen handling procedure.A field service engineer (fse) was dispatched to further investigation the reported event.There was no indication of patient intervention or adverse health consequences due to the discrepant estradiol (e2) patient results.

• 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: 9513686
• MDR Text Key: 220573383
• Report Number: 8031673-2019-00519
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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