MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. (OHIO) AIA-360; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-360 IMMUNOASSAY ANALYZER REFURBISHED

Device Problem Failure to Deliver (2338)

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

Event Date 06/07/2023

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 by attempting to run the daily check.Per fse, the substrate has been replaced multiple times, daily checks have been conducted, and during the process, the 4mu background reading was between 500 and 800(nmol/l), and replacement hand error err occurred.The err code shows that there is a problem with the substrate itself and only occurs on a daily check with faulty substrate.Fse resolved the complaint by replacing the substrate 3-way solenoid valve and the substrate solution.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 27878504r from 07may2022 through aware date 07jun2023.There were no similar complaints identified during the search period.The aia-360 operator's manual under section7-2: list of flags: dl flag the substrate dispensing amount is less than the specified amount or lamp intensity of the fluorescence detector is low.If the dl flag is attached, replace the substrate in the mainte screen, and repeat assay.If the dl flag appears again, contact the service department.Err liquid substitution with the enzyme substrate is insufficient or the lamp intensity of the detector decreased.Check the remaining amount of enzyme substrate and perform the daily check again.If an ¿err¿ appeared again, please ask a tosoh local representative.The most probable cause of the reported event was due to the faulty 3-way solenoid valve.

Event Description

A customer reported "detector or substrate dispense failure (dl flag)" on the aia-360 analyzer.Prior to the call, the customer replaced the substrate, primed the analyzer, and the daily check passed after the substrate replacement, but the flag only occurred on patient samples.Technical support specialist (tss) instructed the customer to perform multiple primes and rerun a sample and the customer will call back to provide feedback.Technical support specialist (tss) contacted the customer and the error persists, 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.

Manufacturer Narrative

Correction: section h6 under component code was corrected from 3050 device ingredient or reagent to 527 valve.

• Brand Name: AIA-360
• Type of Device: FLUOROMETER, FOR CLINICAL USE
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC. (OHIO); 3600 gantz rd; grove city OH 43123
• Manufacturer Contact: jorge porras ; shiba-koen first building; 3-8-2 shiba; minato-ku 10586-23 ; JA 1058623 ; 6506368314
• MDR Report Key: 17201168
• MDR Text Key: 318112728
• Report Number: 3005529799-2023-00037
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• 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 REFURBISHED
• 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: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2020
• 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