MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-900; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-900

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/22/2021

Event Type  malfunction  

Event Description

A customer reported sporadic error message "3004 liquid leak detected" when changing wash and diluent reagents on the aia-900 analyzer.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delayed reporting of patient samples for estradiol (e2) and prolactin (prl).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.Fse confirmed the complaint by reviewing the error logs, but was unable to reproduce error.Fse cleaned the liquid leak sensor s172 with alcohol and canned air but the error reoccurred the next morning.Fse replaced the lqc board which resolved the error.Fse successfully validated the analyzer by performing quality control run, which completed without error within acceptable range.No further action required by field service.The aia-900 analyzer is functioning as expected.A 13-month complaint history review and service history review through aware date of event for similar complaints was performed for serial number (b)(4).There were no other similar complaints found during the searched period.The aia-900 operator's manual under section 12: flags and error messages states the following: [3004] liquid leak detected.Cause: the drain sensor s172 detected liquid.In this case, measurement will be paused.Action: please contact tosoh local representatives.If there is no liquid leakage, check s172.The most probable cause of the reported event is due to failure of the lqc board.

Manufacturer Narrative

The lqc board was returned to tosoh instrument service center for investigation.Functional testing did not confirm the reported event was due to failure of the lqc board.The most probable cause of the reported event is unknown, cause could not be traced to device.

• Brand Name: AIA-900
• 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: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12888736
• MDR Text Key: 285064479
• Report Number: 3004529019-2021-00076
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189283992
• UDI-Public: 04560189283992
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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