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

Model Number AIA-360 IMMUNOASSAY ANALYZER

Device Problem Infusion or Flow Problem (2964)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

A customer reported ¿sample clot (sc flag)¿ while running calibration and quality control (qc) on the aia-360 analyzer.The customer restarted the analyzer and performed multiple sample nozzle flushes, but the flag 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 progesterone (prog iii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A field service engineer (fse) was dispatched to address the reported event.Fse confirmed the complaint by reviewing the printouts of multiple sample clot errors and noticed 4017 specimen syringe clot error had also occurred.Fse could visually see the serum trail from the sample nozzle between the test cup and the sample cup on the incubator cover indicating a clot had been aspirated.The customer had performed several shutdowns and startups prior to fse arrival.As a preventive measure, fse performed testing using eight total triiodothyronine (tt3) test cups with water as samples and no errors reoccurred.The customer validated the analyzer by successfully performing daily check, ran 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)(6) from (b)(6) 2022 through aware date (b)(6) 2023.There were no similar complaints identified during the search period.The aia-360 operator's manual under section7-2: list of flags states the following: sample clot (sc flag) dispensing was cancelled because clogging was detected during sample suction.Check that the sample is free of fibrin or other substances.If the sample is not clouded, the sample nozzle may be faulty or the piping may be blocked.If this problem occurs frequently, contact the service department.The aia-360 operator's manual under section7-1: error messages states the following: (4017) spec.Sy clog detected description: specimen clog was detected.Troubleshooting: the item is not assayed.Repeat assay.The most probable cause of the reported event could not be establish, error cleared after several analyzer restart.

• 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: 17386464
• MDR Text Key: 319756268
• Report Number: 3004529019-2023-00375
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• 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: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1