MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

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

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

Event Date 10/07/2019

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 confirm or reproduce the issue.The fse verified all adjustments and temperatures, and all were within range.A precision test was performed on calibration level 3 and mac controls; all were within ranges.The customer then analyzed new patient samples, and all results were within the patient clinical range.The aia-360 analyzer operated as expected and 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 07sep2018 to aware date 07oct2019.No other similar complaints were identified during the search period.The st aia-pack e2 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 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.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 regards to concomitant medications administered to the patient.The probable cause of the issue could not be determined with the available information.All related mdrs associated with this event: 8031673-2019-00429, 8031673-2019-00452, 8031673-2019-00453, 8031673-2019-00454.

Event Description

A customer reported receiving high estradiol (e2) results on five different male patient samples analyzed on the aia-360 analyzer.This is report 5 of 5.The customer retested the samples three days later and received lower e2 results.The samples were refrigerated and had not been poured off.The customer uses sodium (na) heparin tubes.Technical support explained to the customer that the proper way to store samples is to pour off the plasma from the tube and store in the refrigerator up to 24 hours.Over 24 hours, samples should be frozen.The customer requested to have the field service engineer (fse) return to verify the analyzer as periodic maintenance was performed one week prior to the issue.The customer now pours off the plasma and freezes the samples.A few samples were then analyzed and again generated different results.All controls were within range.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.

• Brand Name: AIA-360
• Type of Device: AIA-360
• 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 o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9287708
• MDR Text Key: 220347180
• Report Number: 8031673-2019-00455
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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