MAUDE Adverse Event Report: TOSOH HI-TEC, INC. AIA-2000; FLUOROMETER, FOR CLINICAL USE

Model Number AIA-2000 ST

Device Problem Decreased Sensitivity (2534)

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

Event Date 09/29/2022

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.Fse was not able to reproduce the complaint because the error did not occur while troubleshooting.Fse noticed the eki liquid ad value was low on the main arm sample nozzle, causing it not to detect when the tip was getting detached.Fse resolved the complaint by adjusting the liquid ad value from 797 to 915.Fse follow-up with the customer and confirmed the error codes no longer appeared.Fse validated the analyzer by successfully performing quality control run passed and within published package insert range.No further action required by field service.The aia-2000 analyzer is functioning as expected.The aia-2000, serial number (b)(4), was installed on (b)(6) 2022.A complaint and service history review for similar complaints was performed from installation date (b)(6) 2022 through aware date 29sep2022.There were no other similar complaints identified during the searched period.Aia-2000 operator's manual on the appendix 4: error messages: (2075) air detected during specimen suction by main arm cause: after specimen suction, it was determined that the tip failed to touch the liquid surface even though the specimen level was 2 mm or higher than the bottom of the container.If retry fails, the measurement result will be flagged (mf flag).Solution: ensure that the specimen is in the correct position and is free from bubbles.If retry fails, contact tosoh service center or local representatives.(2061) tip detachment failure by main arm cause: a tip was detected by tip detachment check.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to low eki liquid ad value on the main arm sample nozzle.

Event Description

A customer reported error message ¿2075 air detected during specimen suction by main arm and 2061 tip detachment failure by main arm¿ on the aia-2000 analyzer.A field service engineer (fse) was dispatched to address the reported event which resulted in a delayed reporting of patient samples for alpha-fetoprotein (afp).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

A review of the device history record (dhr) was conducted for serial number (b)(6), which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the decreased sensitivity of the eki board.

Manufacturer Narrative

Serial number correction from section h10 follow-1: a review of the device history record (dhr) was conducted for serial number (b)(6), which confirmed that there were no nonconformance, failures, discrepancies, or missed steps during the manufacturing process that could be related to the decreased sensitivity of the eki board.

• Brand Name: AIA-2000
• 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: 15646213
• MDR Text Key: 307176954
• Report Number: 3004529019-2022-00176
• Device Sequence Number: 1
• Product Code: KHO
• UDI-Device Identifier: 04560189284616
• UDI-Public: 4560189284616
• 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,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000 ST
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2021
• 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