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

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Failure to Align (2522)

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

Event Date 11/21/2022

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 and was not able to duplicate the problem.While troubleshooting, fse attempted to look for something internal that could have restricted the turn table movement and noticed the flag for the turntable sensor was close to hitting the sensor.Fse resolved the complaint by adjusting the turntable sensor flag to ensure the flag was positioned properly in the sensor.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.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 21oct2021 through aware date 21nov2022.There were no similar complaints identified during the search period.The aia-360 operator's manual under section 7-1: error messages states the following: (4002) turn table home sensor description: the home position of the turntable motor cannot be detected.Troubleshooting: turn the power off and on again.If this problem reoccurs, contact the service department.(4004) turn table home slip description: the turntable motor slipped.Troubleshooting: 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 misaligned turntable sensor.

Event Description

A customer reported error message ¿4002 turn table home sensor and 4004 turn table home slip¿ on the aia-360 analyzer.Technical support specialist (tss) instructed the customer to turn the analyzer off and on, but the error persisted and a loud grinding noise occurred.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 estradiol (e2).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: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 16135140
• MDR Text Key: 308838243
• Report Number: 3004529019-2023-00231
• 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
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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