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 04/01/2020

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 imprecision by reviewing qc results on e2.To reproduce the imprecision, fse ran samples with the covers removed and observed inconsistencies in substrate dispensing, which produced bubbles instead of a steady stream.Fse inspected the substrate tubing, which was improperly routed between the substrate housing and back cover, causing the line to be pinched.Fse re-routed the tubing and observed the substrate replacement cycle which resolved the issue.Fse ran precision on level 2 and level 3 e2 qc samples.Qc run was completed without error, and in acceptable range.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 under chapter 2 - installation procedure provides detailed installation procedure on how on substrate tubing installation.The most probable cause of the reported event was due to substrate tubing improperly routed by operator causing tubing to become pinched.

Event Description

A customer reported out of range quality control (qc) results for estradiol (e2) on the aia-360 analyzer.The customer stated they've had to run same qc material several times before getting acceptable result range.Customer previously ran e2 the first time and it was out of range high and then the second attempt, run dropped by as much as 50%.On (b)(6) 2020 the customer performed another e2 qc run and results for level 2 (l1) 266.2 (acceptable range 167 to 311 pg/ml) which was in range and level 3 (l3) was 2032 (acceptable range 1021 to 1897 pg/ml) was out of range high.Technical support specialist (tss) instructed the customer to re-run the original l3 a second time from the original qc sample cup and then pour another sample cup and re-run e2 4 times from the sample cup as a precision.The customer followed up after re-run and the first run of l3 e2 was 2032 pg/ml, same cup re-run was now at 1653 pg/ml, which confirms the customer's complaint.The precision e2 results were 1711.3, 1698.7, 1635.0, 1995.7 pg /ml which also confirms imprecision.The customer prepared the qc by pouring qc material into the sample cup and then allowed it to rest at room temperature for 25 to 30 minutes prior to running.Prior to calling tss, the customer stated they performed the quarterly decontamination of the analyzer and all supply bottles thinking they may have had a contamination issue, but the issue persists.The analyzer is down.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.

Manufacturer Narrative

Correction: h10 a 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(6) from (b)(6)2019 through aware date (b)(6)2020.There were four (4) similar complaints identified during the searched period, which includes this 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
• MDR Report Key: 10007934
• MDR Text Key: 199043551
• Report Number: 8031673-2020-00124
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• 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: 07/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1