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

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/03/2023

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 log and attempted to run quality control (qc) and received clog detected errors.Fse replaced the sample nozzle and the problem persisted as well as receiving intermittent short sample errors.Fse also replaced the pressure sensor and the 2-way valve.In addition, fse attempted adjusting clog detection adjustment and the problem persisted.Then fse replaced the sensor board and found the sample height detector missing a spring and replaced it; adjusted the clot ad detection, liquid ad, voltage, and adjusted the temperatures that were within range.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-360 analyzer is functioning as expected.The aia-360, serial number (b)(6), was installed on (b)(6) 2023.A complaint history review and service history review for similar complaints was performed from installation date 21sep2023 through aware date 03oct2023.There were no other similar complaints identified during this searched period.The aia-360 training manual under section troubleshooting: flag definitions and corrective measures: (sc) sample clot cause: sample clot detected by sample probe.Resolution: repeat test with fresh fibrin free sample.The most probable cause of the reported event was due to the failures of the: 2-way valve, pressure sensor, pcb sensor, cable, sensor board, and sample height detection unit.

Event Description

A customer reported ¿sc sample clogging¿ flag during patient sample runs and quality control (qc) on the aia-360 analyzer.Prior to the call, the customer restarted the analyzer and primed the sample nozzle, but the flags reoccurred, 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), estradiol (e2), progesterone (prog iii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

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: 18027230
• MDR Text Key: 326808040
• Report Number: 3004529019-2023-00447
• 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: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2023
• 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: 12/01/2022
• 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