MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the reported error via the error log.The fse was able to reproduce the error by moving a rack through the sample loader.The fse found that when trying to move the belt feed in the y3 position in maintenance the belt would not move.This prevented the rack from transferring from x3 to y3 feed.After a closer look, the fse found that there was a spill which had dried up and it did not allow the belt to move in the y3 position.The fse was able to clean around the belt and underneath the belt feed removing the sticky spill.After clean up, the fse was able to start and stop the y3 belt feed in maintenance mode.The aia-2000 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 30sep2019 through aware date 30oct2020.There were no similar complaints identified during the searched period.The most probable cause of the reported event was a dried substance which caused the sticky y3 belt feed not to move preventing transfer from x3 to y3 position.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 2262, unable to transport rack in to x3 transfer-in position on the aia-2000 analyzer.Customer indicated that she had tried running the rack with 4 specimens twice now.The technical support specialist (tss) try a different rack.Customer tried a different rack and the samples went through but the empty rack error occurred.Customer was not able to find any defects with the racks.A field service engineer (fse) was dispatched to address the reported issue which caused a delay in reporting human chorionic gonadotropin (hcg) 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-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minaot-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 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: 10906411
• MDR Text Key: 219134826
• Report Number: 8031673-2020-00351
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2020

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-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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