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

Model Number AIA-900

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423)

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

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer¿s site to address the reported event.Fse stated the customer also reported out of range low free thyroxine (ft4) quality control (qc) and out of range high thyroid stimulating hormone (tsh) qc.Fse was able to reproduce the complaint when running the customer¿s quality controls (qc).Fse replaced the sample nozzle and adjusted the clot detect.Fse also verified the alignments and reran qc, ft4 was still low and tsh high.After replacing the sample nozzle and running qc, fse recalibrated ft4 and noticed an increase on level 2 control.Then, fse recalibrated tsh and qc is now within acceptable ranges.Fse repaired and validated the analyzer by successfully performing quality control run without error 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 for similar complaints was performed for the serial number (b)(4) from 26dec2021 through aware date 26jan2023.There were no similar complaints identified during the search period.The st ft4 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 ft4, the highest concentration of free thyroxine measurable is approximately 8.0 ng/dl, and the lowest measurable concentration is 0.10 ng/dl (assay sensitivity).Although the approximate value of the highest calibrator is 9.0 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, 8.0 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.Circulating autoantibodies to t4 may interfere with the free thyroxine measurements.Hormone-binding inhibitors may interfere with the free t4 assay.Heparin may cause in vivo effects in free t4 assays.Blood collection for free t4 assays should not be performed concurrent with administration of heparin therapy.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.Drugs which affect the binding of t4 to the thyroid hormone carrier proteins or affect the metabolism of t4 to t3 may complicate the interpretation of free thyroxine results.In patients with severe non-thyroidal illness (nti) in whom the free t4 yields results indicating hypothyroidism, it is suggested that the aia-pack tsh 3rd-gen or st aia-pack tsh assay be run to confirm this diagnosis.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.The st tsh 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 tsh, the highest concentration of thyroid stimulating hormone measurable without dilution is approximately 100 iu/ml, and the lowest measurable concentration is 0.03 iu/ml (assay sensitivity).Although the approximate value of the highest calibrator is 100 iu/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, 100 iu/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 thyroid stimulating hormone.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.The most probable cause of the reported event was due to a partial obstruction of flow of the sample nozzle.

Event Description

A customer reported mechanical problem with the sample dispensing arm on the aia-900 analyzer.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for estradiol (e2).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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: 16415525
• MDR Text Key: 309988854
• Report Number: 3004529019-2023-00265
• 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: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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