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 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: 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 similar complaints identified during the search period.The st aia-pack estradiol (e2) analyte application manual states the following: procedural notes: if a serum or plasma specimen estradiol concentration is found to be greater than the linearity limit of the assay, 3000 pg/ml; the specimen should be diluted with the aia-pack e2 sample diluting solution and re-assayed according to the assay procedure.The recommended dilution for samples containing greater than 3000 pg/ml is 1:10.It is desirable to dilute the serum or plasma sample so that the diluted sample reads between 100 and 500 pg/ml.The dilution factor should be entered into the software.For further information on the dilution of specimens, refer to the aia system operator's manual.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, two levels of controls are run in order to accept the calibration curve.The two 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.The aia-360 operator manual, list of error messages.[2015] bf probe purge failure is generated when purging by the bf probe is abnormal.Operator is instructed to clean up the wash probe tip or replace it.Contact the local service department.The most probable cause of the reported event was due to biological contamination of the analyzer.

Event Description

A customer reported getting discrepant results of estradiol (e2) on the aia-360 analyzer.The customer stated a dilution was done due to greater than high result.A dilution of 1:20, 380ul sample diluting solution (sds), 20ul sample, produced 1938 pg/ml result.A repeat of same dilution produced 2022 pg/ml result.A higher result was expected based on patient's clinical history; therefore, the customer sent out the sample to a reference lab for confirmation and a result of 4000 pg/ml was obtained.The customer confirmed the qc on the aia-360 analyzer was in acceptable range.Technical support specialist (tss) instructed the customer to perform a full decontamination of the analyzer, also noted that the last decontamination performed by the fse was in april 2019 due to high coefficient of variations (cv).The customer followed up to report receiving error 2015 "bf probe purge failure" when priming the reagent grade water through the reagent lines, while performing the decontamination procedure.The tss informed the customer to continue with the decontamination procedure, error 2015 is a common error when priming only water through the lines.Tss followed up with the customer, and customer confirmed all assays, controls and repeated patient sample runs are successful and within acceptable range.No further action required.The aia-360 analyzer is functioning as expected.There is no indication of any patient intervention or adverse health consequences due to the discrepant patient results.

• 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: 9386151
• MDR Text Key: 219773096
• Report Number: 8031673-2019-00478
• 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: 11/27/2019

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-360
• Device Catalogue Number: 019945
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2015
• 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