MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the error via the error log.The fse was unable to reproduce the intermittent error due to time constraints and replaced the cps-board, cprb board, and pip electric board along with the geared stepping motor.The fse performed hybrid arm mechanical and maintenance alignments.The fse also returned to the site a few days later to replace the hybrid arm main cable as a precaution to avoid further intermittent errors.Customer ran around 600 tests without any errors.The fse also ran several macros for cup transfer without problems.The instrument was validated by running quality control (qc) and patient's qc passed and was within published customer ranges.The aia-2000 analyzer is functioning as expected.No further action required by field service.The following parts were returned to tosoh instrument service center for investigation.The pip board was installed onto a test bed analyzer and the error could not be replicated.The part passed.The hybrid arm cable assembly was installed onto a test bed analyzer and the error could not be replicated.The part passed.The cprb board was installed onto a test bed analyzer and the error could not be replicated.The part passed.The geared stepping motor was installed onto a test bed analyzer and the error could not be replicated.The part passed.The cps board was installed onto a test bed analyzer and the error could not be replicated.The part passed.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 02oct2019 through aware date (b)(6) 2020.There were no similar complaints identified during the searched period.The aia-2000 operator's manual under section 04 - error messages states the following: [2151] hybrid arm/cup transfer cup pickup failure.Cause: the cup gripping sensor failed to detect a cup after the cup pickup operation was performed.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event is unknown.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer reported an error 2151 hybrid arm/cup transfer cup pickup failure.The aia-2000 analyzer is down.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting beta human chorionic gonadotropin (bhcg), follicle stimulating hormone (fsh) and prolactin (prl) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A 13-month complaint and service history review for serial number (b)(6) from the date of (b)(6) 2019 through aware date of (b)(6) 2020 was performed for similar complaints.There were two similar complaints including this one identified during the search period.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 10935647
• MDR Text Key: 229563850
• Report Number: 8031673-2020-00354
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1