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 08/17/2023

Event Type  malfunction  

Event Description

A customer reported error messages ¿2011 air detected (sample)¿ during sample drawing and ¿2014 sample shortage detected¿ while running quality control (qc) on the aia-360 analyzer.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 beta human chorionic gonadotropin (bhcg), estradiol (e2), luteinizing hormone (lh ii), and 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 at the customer¿s site to address the reported event.Fse confirmed the complaint when attempting to run quality control (qc) on the analyzer and the error reoccurred as the sample nozzle was drawing a sample from the sample cup.Fse noticed the sample nozzle was not going down to collect sample from the sample cup, hence resulting in reported error.Fse replaced the level sensor (pcb board) which allowed the nozzle to detect liquid.Fse repaired and validated the analyzer by successfully performing liquid level sense routine and quality control run without error and within acceptable range.No further action required by field service.The aia-360 analyzer is functioning as expected.The aia-360, serial number (b)(6), was installed on (b)(6) 2022.A complaint history review and service history review for similar complaints was performed from installation date (b)(6) 2022 through aware date (b)(6) 2023.There were no other similar complaints identified during this searched period including this case.The aia-360 operator's manual under section7-1: error messages states the following: (2011) air detected (sample) description: there is no contact with the liquid surface after sample suction.Troubleshooting: contact the service department.(2014) sample shortage detected description: insufficient sample.Troubleshooting: prepare enough volume of specimen.The most probable cause of the reported event was due to the faulty level sensor (pcb board).

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number (b)(6), which confirmed that there were no nonconformance, failure, 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: 17759401
• MDR Text Key: 323739584
• Report Number: 3004529019-2023-00417
• 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: 12/08/2023

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: 08/17/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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