MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Computer Software Problem (1112)

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

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed and replicated the issue by operating the keyboard and hand-held barcode scanner.The fse applied technical information procedure tbi-002-022620 to correct the computer compatibility issue.Quality control (qc) was then performed; results were within the published ranges.Patient samples generated normal results.The aia-2000 instrument returned to normal operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 27jun2019 to aware date 27jul2020.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: when the aia-2000 reads the specimen id barcode, it searches the database for an existing assay request.If not found, it queries the host computer.If an assay request for the specimen id is still not found, the specimen is skipped.Operating modes.The aia-2000 system provides three basic operating modes.These are non-barcode, barcode and host query modes.System operation format differs according to whether specimens are supplied using the built-in sample loader unit or an external beltline unit.2.8.1 non-barcode mode as the name indicates, specimens are processed without the use of individual specimen barcodes.Assay request information is entered manually from the controller pc or downloaded from host computer prior to assay operations.Once a specimen container is detected, assay operation commences, starting in order with the first container in accordance with the assay request information.(note that non-barcode mode cannot be used with beltline operation.) 2.8.2 barcode mode: in barcode mode, assay request information is entered manually from the controller pc or downloaded from the host computer prior to assay operations.When a specimen container barcode is read, the system extracts information for that barcode from the assay request information received from the controller pc and performs the specified assay operation.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.The probable cause of the issue is attributed to faulty computer software.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported unable to enter specimen id with the keyboard or the barcode scanner on the aia-2000 analyzer.The customer performed a system reboot; however, the issue remained.An fse was notified.A field service engineer (fse) went onsite to address the reported issue, which resulted in the delay of reporting intact parathyroid hormone (ipth) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10443084
• MDR Text Key: 206584196
• Report Number: 8031673-2020-00224
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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