MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

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

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the error on the error log; however, could not reproduce the issue.The fse noticed dried serum buildup on the sample nozzle and replaced the sample nozzle.The fse then primed the system and verified nozzle alignments.Impasse sense was then run and passed.Daily check and controls performed also passed.The aia-360 instrument returned to normal operation.No further field action required.The suspect nozzle assembly was returned to tosoh instrument service center for investigation.A visual inspection revealed no shipping damage.Functional testing was performed by installing the nozzle assembly in an aia-360r test bed instrument.The nozzle was aligned per the compound action.Controls were run to check for clogged nozzle.A 10-point precision test was performed on level 3 control without any error.The reported issue could not be replicated.The nozzle assembly functioned as expected.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 29jun2019 to aware date 29jul2020.One other similar complaint was identified during the search period.The aia-360 operator's manual states the following: [4017] spec.Sy clog detected.Description: specimen clog was detected.Troubleshooting: the item was not assayed.Repeat assay.The probable cause of the issue 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

A customer reported receiving error 4017 spec.Sy clog detected on the aia-360 analyzer.The customer stated the error occurred a few times the week before and becoming more frequent.The error occurred during calibration when attempting to calibrate prostate-specific antigen (psa).The customer stated the laboratory called at the end of june 2020 with clogging errors as well.An fse was dispatched.A field service engineer (fse) went onsite to address the reported issue, which resulted in the delay of reporting luteinizing hormone ii (lh ii) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• Brand Name: AIA-360
• Type of Device: AIA-360
• 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: 10443085
• MDR Text Key: 206787353
• Report Number: 8031673-2020-00229
• 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: 08/18/2020

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-360
• Device Catalogue Number: 019945
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• 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