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

Model Number AIA-900

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

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

A customer reported discrepant results for progesterone (prog iii) on the aia-900 analyzer.The patient physician questioned the results and sent patient samples to a reference lab that is using a roche e2600 for retesting.The customer stated all quality control (qc) results were within acceptable range and no calibration issues.The customer replaced the wash and diluent and reran samples but error persisted.A technical support specialist (tss) sent prog iii sample diluting solution (sds) to the customer and the customer retested samples again using the sds in triplicate and error persisted.The analyzer is down.There was no indication of any patient intervention or adverse health consequences due to the reported event.

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the problem by comparing the results to another instrument.The fse checked the substrate and wash and looked for signs of leaks and no issues were noted.The fse checked the detector lens and found that the lens was dirty.The fse cleaned the detector lens and ran controls.The resolution was verified by calibrating and running quality control (qc).No further action is required by field service.The aia-900 analyzer is functioning as expected.A complaint history review and service history review from the install date through the aware date of the event for similar complaints was performed for serial number (b)(6).There were no similar complaints identified during the searched period.The st prog iii 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 progiii, the highest measurable concentration of progesterone in specimens without dilution is 40 ng/ml, and the lowest measurable concentration in specimens is 0.1 ng/ml (assay sensitivity).Although the approximate value of the highest calibrator is 45 ng/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, 40 ng/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.Samples from patients who had an injection of fluorescein, which is used in fluorescein fundus angiography, may cause 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.Heterophile antibodies are known to interfere in assays of this type.St aia-pack progiii has been designed to minimize the effects of heterophile antibodies, but interference from high titers cannot be ruled out.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 a dust or dirt problem, cause traced to environment.

• 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: 18728604
• MDR Text Key: 336623669
• Report Number: 3004529019-2024-00513
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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