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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was unable to confirm the reported problem as the customer stated that much of the testing was with a different analyzer and even different methodology than the aia-360 analyzer.The fse was unable to reproduce the problem as the quality control (qc) runs withing specification.The fse investigated the wash system, waste system and tubing and was unable to find anything wrong.The fse replaced the wash probe as a precautionary measure although no evidence indicated that it is failing.The fse reseated the tubing to waste pump, checked all carousel cup positions to ensure that it was moving freely.The detector lens were also cleaned.The fse also checked the substrate dispense and it was good.A daily check was ran and customer prepared qc two times to verify that all operation passed.The aia-360 analyzer is functioning as expected.No further action required by field service.The clinical support specialist is planning a site visit to investigate customer specimen handling and lab practices.The wash probe was returned to tosoh instrument service center for investigation.Evaluation of the part passed during testing.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 14jul2019 through aware date (b)(6).There was one similar complaint identified during the searched period.The most probable cause of the reported event could not be determined.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer reported that results are not correlating.The initial results for estradiol (e2), progesterone (prog ii), and beta human chorionic gonadotropin (bhcg) were not correlating with the reference lab.The reference lab is lab corp.Which uses chemiluminescent analyzer for hormone testing.The lab tech ran the quality control (qc) and all was in range and there were no analyzer issues.The nurse ran four different patient samples on the aia-360 which did not correlate.The account uses sst serum tube and spins them for ten minutes prior to analysis.The caller that reported the issue does not perform testing and was uncertain if fibrin, clot, or bubble in tube.The primary tubes run on analyzer and when needed tosoh sample cups are used.The analyzer is performing as expected and no analyte imprecision observed.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting estradiol (e2), progesterone (prog ii) and beta human chorionic gonadotropin (bhcg) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of 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, tokyo 10586 23; JA 1058623
• MDR Report Key: 10523640
• MDR Text Key: 229123696
• Report Number: 8031673-2020-00251
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1