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

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at the customer's site to address reported event.The customer reported getting errors 2012 and 4004.Fse confirmed the complaint by reviewing the error logs and reproduced errors by attempting to move the turn table manually and the carousel would not move.Fse replaced the bent sample needle.Fse also found the sample detection spring was broken and not touching the case of the eki board.The broken piece was inside of the carousel pitch sensor and jamming it, preventing free movement of the carousel.Fse removed the broken piece of the spring which freed the carousel.Fse cleaned the carousel, z axis of the sample arm and verified all alignments of the sample nozzle.Fse 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.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 two (2) similar complaints identified during the searched period, which includes this event.The aia-360 operator's manual under chapter 7, section 7.1: list of error messages states the following: air detected [diluent] is generated when there is no contact with the liquid after diluent suction.The operator is instructed to contact the service department.Turn table slip is generated when the turntable motor slipped.The operator is instructed to turn the power off and on again.If this problem reoccurs, contact the service department.The most probable cause of the reported events were due bent sample nozzle and a broken sample detection spring.

Event Description

A customer reported getting error message 2012 ¿air detected [diluent]¿ on the aia-360 analyzer.While troubleshooting with the customer over the phone, the technical support specialist (tss) noted the sample nozzle was bent.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) and cardiac troponin i (ctnl2).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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: bernadette o connell ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368143
• MDR Report Key: 12485687
• MDR Text Key: 271900022
• Report Number: 3004529019-2021-00031
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• 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: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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