MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-900

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

A customer reported discrepant patient result for testosterone (tes) on the aia-900 analyzer.The patient sample was drawn on (b)(6) 2023 and both serum and plasma were collected.The customer used lithium heparinized tubes for plasma collection.Plasma was ran on the tosoh aia-900 analyzer two times with the results being 1477.84 ng/dl and 1473.30 ng/dl (tosoh assay range 10 ng/dl-2200 ng/dl).The customer refrigerated the same tube and sent to reference lab to analyze the same day.The reference lab uses a siemens attelica analyzer and the patient test results were 317 ng/dl and 355 ng/dl (siemens range 7 ng/dl-1500 ng/dl).The customer was expecting a lower patient test result.The customer asked the technical support specialist (tss) if there could be possible sources of interference, tss advised a non exhaustive list, but will consult with a tosoh aia project manager.The customer also has a copy of the analyte application manual (aam) for further information.No results were reported out and no treatment plan was altered.There is no indication of any patient intervention or adverse health consequences due to the reported discrepant patient result.

Manufacturer Narrative

A technical support specialist (tss) updated the customer with the tosoh aia project manager response stating testosterone is also produced (in small quantities) in the adrenal gland in both males and females.The project manager also stated cross reactivities, further explaining that if any are present in the specimen at the same concentration as testosterone, the final result will be increased by the following percentages: substance concentration added (ng/dl) cross-reactivity (%) androstenedione 200000, 1.71.Dhea 5000, 0.10.5 - dihydrotestosterone 1000, 0.81.Ethyltestosterone 600 ,0.15.No further action required by technical support specialist.The aia-900 analyzer is functioning as expected.A complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(6).There were no other similar complaints found during the searched period.The st tes, analyte application manual states the following: interference is defined, for purposes of this study, to be recovery outside of 10% of the known specimen mean concentration.For these studies, interfering substances are added to normal human serum.Added hemoglobin (up to 500 mg/dl), conjugated bilirubin (up to 21.1 mg/dl) and free bilirubin (up to 17.0 mg/dl) do not interfere with the assay.Lipemia, as indicated by added triglyceride (up to 500 mg/dl) does not interfere with the assay.Added albumin (up to 5 mg/ml) does not interfere with the assay.Added ascorbic acid (up to 20 mg/dl) does not interfere with the assay.Added rheumatoid factor (up to 45 iu/ml) does not interfere with the assay.Tosoh automated immunoassays utilizing alkaline phosphatase-based technologies should not be used with samples from patients under asfotase alfa treatment.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 testosterone, the highest concentration of testosterone measurable without dilution is approximately 2200 ng/dl, and the lowest measurable concentration is 10 ng/dl (assay sensitivity).Although the approximate value of the highest calibrator is 2200 ng/dl, the exact concentration may be slightly different.The assay specification, assay range high, should be defined as the upper limit of the assay range, 2200 ng/dl.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.Samples from patients who had an injection of fluorescein, which is used in fluorescein fundus angiography, may cause falsely elevated results.Samples containing fibrin may exhibit either falsely elevated or falsely decreased results.Fibrin must be eliminated in the sample before assay begins.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 most probable cause of the reported discrepant result was possibly due an interference in the sample, cause not established.

• Brand Name: AIA-900
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 17114768
• MDR Text Key: 317216408
• Report Number: 3004529019-2023-00345
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• 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: 022930
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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