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

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer¿s site to address the reported event.Fse confirmed the complaint by reviewing the error logs.The fse powered off and on, moved the wash syringe by hand to test functionality.Fse replaced the washer syringe assembly, cable (lqc board to cn2) and (s100) pip electric board.Fse repaired and validated the analyzer by successfully performing quality control run without error and 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)(6).There were no similar complaints identified during the searched period.The aia-900 operator's manual under section 12 - flags and error messages states the following: (4251) wash-syr home detect error.Cause: the home sensor s100 failed to be activated after the wash syringe moved toward the home position.No further operation will take place.Action: remove the impediment or other cause of the error.Check s100 and pm100 for a possible malfunction.The most probable cause of the reported event was due to the failures of the washer syringe assembly, cable, and (s100) pip electric board.

Event Description

A customer reported error message ¿4251 wash-syr home detect error¿ during startup on the aia-900 analyzer.The customer powered the analyzer off and on.Technical support specialist (tss) instructed the customer to observe the bf probes and the tips were seated properly and performed an all-home-set, the error persists.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 beta human chorionic gonadotropin (bhcg).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

The pip electric board, washer syringe assembly, and cable (lqc board to cn2) were returned to the instrument service center for investigation.A visual inspection was performed on the returned parts and found the pip electric board was damaged and does not met specifications, therefore leading to component failure.No visual damage for the washer syringe assembly and cable was observed.Functional testing was performed using a digital multimeter and no open circuits were found.The washer syringe assembly and cable passed within specifications and no device problem was found.The most probable cause of the reported event was due to the faulty pip electric board.

• 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: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 18342263
• MDR Text Key: 331063103
• Report Number: 3004529019-2023-00484
• 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
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2023
• 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: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• 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