MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

A 13-month complaint history review for similar complaints was performed for lh ii lot number jx13944 from 09jun2019 to aware date (b)(6) 2020.No other similar complaints were identified during the search period.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 09jun2019 to aware date (b)(6) 2020.No other similar complaints were identified during the search period.The st aia-pack lh ii 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, 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.This issue is under further investigation.

Event Description

A customer reported luteinizing hormone ii (lh ii) failed three (3) samples in the cap survey proficiency testing on the aia-900 analyzer.All samples had elevated, out of range results.It was noted that the calibration rates were low compared to the calibration from the tosoh qa laboratory.Technical support advised the customer to perform a full decontamination of the analyzer.A new calibrator was sent to the customer.The customer later reported the recalibrated rates of lh ii and results were still low which caused the controls to be high.The customer performed the decontamination and made new reagents without any change in the lh ii controls.A field service engineer (fse) was dispatched.A field service engineer (fse) was dispatched to address the reported issue.There was no report of patient intervention or adverse health consequences due to the event.

Manufacturer Narrative

Device evaluation: h6 a field service engineer (fse) evaluated the instrument onsite.The fse noted lh ii quality control (qc) results generated by the aia-900 instrument were within the acceptable ranges.The customer will order new samples from cap survey to run their test.The issue could not be replicated.The aia-900 instrument is performing as expected.There was no evidence of a device issue.Level 1 qc = 1.2 miu/ml (range 0.800-1.60 miu/ml) level 2 qc = 21.2 miu/ml (range 15.0-27.0 miu/ml) level 3 qc = 71.0 miu/ml (range 57.0-106.0 miu/ml) the probable cause of the issue could not be determined.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 10371262
• MDR Text Key: 239423287
• Report Number: 8031673-2020-00204
• 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: 08/11/2020

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: 022930111
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1