MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer's site to address the reported issue.Fse confirmed reported error from the error log.Fse could not reproduce the problem due to bent nozzle (probe).Fse replaced the sample nozzle, verified sample nozzle alignments, performed pressure test and liquid level sense test; all results passed without error.The customer informed the fse of intermittent 3020 diluent low error, and fse confirmed error from the error log as well.Fse was able to reproduce error while attempting calibration run.Fse cleaned diluent level sensor leads and replaced the lead wire of level sensor.Fse successfully completed sample run, quality control and precision test without any errors; all results were 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 through aware date of event for similar complaints was performed for serial number (b)(4).There were two (2) similar complaints identified during the searched period, which includes this event.The aia-360 operator's manual under section 7-1: list of error messages states the following: [4020] spec.Z-axis home overrun is generated when the specimen z-axis motor overran on the home side.Solution: turn the power off and on again.If this problem reoccurs, contact the service department.[3020] diluent low is generated when there is insufficient diluent.Solution: after confirming that assay displayed on the upper right of the assay monitor screen changes to stop, replace the diluent with new one and press the start key to restart assay operation.The most probable cause of the reported event was due to bent sample nozzle and faulty level sensor lead wire.

Event Description

A customer reported getting "4020 specimen z axis home overrun" error during a sample run on the aia-360 analyzer.The customer stated the sample probe bent while running a sample tube without a cap.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of alpha-fetoprotein (afp) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9263956
• MDR Text Key: 220572425
• Report Number: 8031673-2019-00422
• Device Sequence Number: 1
• Product Code: KHO
• 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
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360
• Device Catalogue Number: 019945
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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