MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-360; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problems Leak/Splash (1354); Component Missing (2306)

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

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) conducted a site visit and was able to confirm the problem by reviewing the print out.The 2-way valve was intermittently, causing cups to come out over full and liquid (diluent/wash) pump was leaking onto the tray.Fse replaced the 2-way valve and liquid (diluent/wash) pump and ran controls.Fse also identified missing backup usb stick and replaced.Fse validated the analyzer by running quality control that was within acceptable range.The aia-360 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(6).There were no similar complaints identified during the search period.The aia-360 operators manual under section 7-1: list of error messages state the following: [2016] bf probe suction failure.Description : suction by the bf probe is abnormal.Troubleshooting : contact the service department.The most probable cause of the reported event was due to failure of the 2-way valve and liquid (diluent/wash) pump.The cause could not be established for the missing backup usb stick.

Event Description

A customer reported error message "2016 bf probe suction failure¿ on the aia-360 analyzer when running patient samples.The customer rebooted the instrument per technical support specialist (tss) instructions and checked the line for the wash to ensure it was not crimped and none were observed.Customer noted a leak when running patient samples.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for intact parathyroid hormone (ipth).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A complaint history review and service history review through aware date of event for similar complaints was performed for serial number: (b)(6).There were no similar complaints identified during the search period.A review of the device history record (dhr) was conducted for serial number: (b)(6), which confirmed that there were no nonconformance, failure, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.

• Brand Name: AIA-360
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer (Section G): TOSOH HI-TEC, INC.; 1-37, fukugawa minami-machi; shunan, yamaguchi 74600 42; JA 7460042
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 17971624
• MDR Text Key: 326136325
• Report Number: 3004529019-2023-00441
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189282896
• UDI-Public: 04560189282896
• 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,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360 IMMUNOASSAY ANALYZER
• 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: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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