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

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Mechanical Problem (1384)

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

Event Date 11/29/2021

Event Type  malfunction  

Event Description

Customer reported an air detect diluent error 2012.A daily check was ran and it was ok; however, the quality controls (qc) ran with error 2012.The priming and reboot did not resolve.This is a reportable event based on delay in reporting of patient results for intact parathyroid hormone (ipth).

Manufacturer Narrative

An investigation was performed in response to a complaint of error 2012 on the aia-360 analyzer.The device was being used for diagnosis during the complaint event.At the customer site, a field service engineer (fse) removed the cover over pumps and found tubing from diluent pump to solenoid valve was kinked.The investigation confirmed that the tubing exhibited obstruction of flow due to component failure.Review of the investigation conclusions indicates that escalation of the complaint for corrective and preventive actions is not warranted.A 13-month complaint and service history review for serial number (b)(4) from the date of 29oct2020 through aware date (b)(6) 2021 was performed for similar complaints.There were no similar complaints identified during the search period.The aia-360 operator's manual under section 7-1: list of error messages states the following: [2012] error message: air detected diluent.Description: there is no contact with the liquid after diluent suction.Troubleshooting: contact the service department.

• 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: 13049511
• MDR Text Key: 284644356
• Report Number: 3004529019-2021-00087
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1