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

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/03/2021

Event Type  malfunction  

Event Description

Customer reported bad precision issue and psa results almost twice as high as expected on several repeated patient samples.This is a reportable event based on potential discrepant patient results for psa.

Manufacturer Narrative

An investigation was performed in response to a complaint of bad precision issue and psa results almost twice as high as expected on several repeated patient samples 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) found evidence of a aspirated clot by the dried serum on incubator cover at #1 sampling position.The fse inspected all and verified nozzle not clogged and replaced 2-way valve for sampling and pressure transducer thinking they may have clot material in them.The investigation revealed an obstruction of flow to the solenoid valve due to a component failure.Review of the investigation conclusions indicates that escalation of the complaint for corrective and preventive actions is not warranted.A complaint and service history review for serial number (b)(4) from the installation date of (b)(6) 2021 through aware date 11/03/2021 was performed for similar complaints.There were no similar complaints identified during the search period.Were there four (4) or more related complaints and / or service records, including this complaint, that had same or similar events (confirmed or not) for the lot or serial number reviewed? no.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number (b)(6), which confirmed that there were no non-conformances, failures, 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: 12888716
• MDR Text Key: 287610661
• Report Number: 3004529019-2021-00073
• 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: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 11/03/2021
• Supplement Dates FDA Received: 02/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1