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 03/31/2020

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 the problem by reviewing the error log and reproduced the problem by priming the substrate, in the process discovered the substrate line was kinked.Fse corrected the kinked line then primed the substrate without errors.Fse successfully performed the daily check and a precision run.No further action required by field service.The aia-360 analyzer 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 other similar complaints found during the searched period.The st aia-pack estradiol (e2) analyte application manual states the following: evaluation of results: quality control: in order to monitor and evaluate the precision of the analytical performance, it is recommended that commercially available control samples be assayed daily.The minimum recommendations for the frequency of running internal control material are: after calibration, three levels of controls are run in order to accept the calibration curve.The three levels of controls are also repeated after calibration when certain service procedures are performed (e.G.Temperature adjustment, sampling mechanism changes, maintenance of the wash probe or detector lamp adjustment or change).After daily maintenance, at least two levels of the control should be run in order to verify the overall performance of the tosoh aia system analyzers.If one or more control sample value(s) is out of the acceptable range, it will be necessary to investigate the validity of the calibration curve before reporting patient results.Standard laboratory procedures should be followed in accordance with the regulatory agency under which the laboratory operates.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-360 operator's manual, section 7-2: list of flags states the following: do: over detector range: no result could be obtained because the measuring range of the detector was exceeded.Dilute the sample as required and repeat assay.The most probable cause of the reported event was due to kinked substrate line.

Event Description

A customer reported out of range quality control results for estradiol (e2) on the aia-360 analyzer.Prior to calling the technical support specialist (tss), the customer prepared fresh qc and performed a run, but that didn't resolve the issue.Tss instructed the customer to check the substrate tubing and move it away from the wall of the bottle if it's against it.The customer confirmed the tubing was not kinked, and tubing was attached at the top of the wash probe assembly.Wash probe tip was also confirmed to be okay.Tss instructed the customer to open and close caps on waste, wash, diluent and reboot analyzer.The customer made fresh wash, diluent and substrate per tss instructions but that didn't resolve the issue; qc was still out of range.The customer was then instructed to perform a decontamination.Calibrators and mac controls were sent to customer for further investigation.The customer decontaminated the analyzer and attempted e2 calibration, which resulted in do flags on all calibrators, but background check passed.Tss instructed the customer to inspect the substrate tubing and wash probe tip again.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of estradiol (e2) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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 oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9986348
• MDR Text Key: 188520875
• Report Number: 8031673-2020-00120
• 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: 04/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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