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

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/18/2021

Event Type  malfunction  

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 and reproduced error by trying to home turn table from maintenance menu.Fse turned off the analyzer and attempted moving the turn table manually but noticed some friction while moving the turn table.Fse cleaned underneath the table and table bearings and lubricated them but that didn't resolve the problem.Fse found the sample holder adapter #6 detached from the turn table which was preventing proper turn table movement.Fse reinstalled the sample holder adapter in place and was able to easily move the turn table manually.Fse turned the analyzer back on, analyzer homed without any problem.Fse tested the turn table by pressing on sample feed button and confirmed the turn table is moving properly and homing every time without any errors.The customer performed 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 no other similar complaints found during the searched period.The aia-360 operator's manual under chapter 7, section 7.1: list of error messages states the following: turn table home not found is generated when the home position of the turntable motor cannot be detected.The operator is instructed to turn the power off and on again.If this problem reoccurs, 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 event was due to the sample holder adapter detached from the turn table.

Event Description

A customer reported getting error messages "4004 turntable slip" and "4002 turntable home not found" during a sample run on the aia-360 analyzer.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) and progesterone (progii).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: 12485661
• MDR Text Key: 271899615
• Report Number: 3004529019-2021-00030
• 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: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1