MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Computer Operating System Problem (2898)

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

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluation by manufacturer: a field service engineering (fse) contacted the customer over-the phone to address the reported event.During troubleshooting, fse instructed the customer to detach and reattach the keyboard and then repower the instrument.However, the customer called back stating that a 35601 element not found error message on the monitor.The customer declined further service as they did not have a contract for service repair.There was no further action required by fse at the time.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2017 through aware date (b)(6) 2018.There were no similar complaints found during the searched period.The aia-2000 operator's manual under chapter 2 system configuration and functionality: 2.8 operating modes 2.8.3 host query mode in host query mode, the system reads the specimen container barcode and searches the controller pc for assay request information corresponding to that barcode.If not found, the system issues the query to the host computer and downloads the necessary information.Assay operation is performed as specified and the results are sent to the host computer.Chapter 6 system operations states the following: 6.6.3.4 assay requests in host-query mode requests issued to the host computer are referred to as "host queries" in the aia-2000 system.Assay requests do not have to be generated when host-query mode is used.The host-query mode setting must be entered to enable the system to query the host computer for assay requests based on scanned barcode information.Click the utilities button on the toolbar to display the specification tab.This is done by selecting the yes in the query status.The most probable cause of reported event was not determined.

Event Description

A customer reported that the screen went black after running on the aia-2000 instrument.The customer powered both the computer and the analyzer off and on twice but the screen remained blank.The customer stated that the power light was on the computer, but the screen display was not focused and the program software would not start.The instrument was down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of follicle stimulating hormone (fsh) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

Tosoh bioscience, inc.Is submitting on behalf of the foreign manufacturer, tosoh corporation, per exemption number e2017013.Submission of this report does not constitute an admission that the importer or manufacturer's product caused or contributed to the event.Corrected date: d10 device available for evaluation: yes.H3: device evaluated by manufacturer: yes.H.3.Device evaluation by manufacturer: a field service engineer (fse) visited the customer to address the reported event.During servicing, fse verified that the original pc did not boot up.Fse replaced the original computer with an "all in one" computer.Fse then performed the daily check, calibration, and then ran quality controls with acceptable results.The instrument was operating as expected.There was no further action required by fse.H6 evaluation codes: method: 10-testing of actual/suspected device, results: 104-software problem identified, conclusion code: 4307-cause traced to component failure.The most probable cause of the reported event was due to failure of the control computer.

• 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: 8220522
• MDR Text Key: 133520758
• Report Number: 8031673-2018-05397
• 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: 02/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2019
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2019
• Distributor Facility Aware Date: 01/17/2019
• Device Age: 3 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/24/2019
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1