MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the reported errors via the error log.The fse was also able to reproduce the error 4151 c trans z home detect by performing an all set home.The fse was unable to reproduce error 4124 sample z bump.The fse was unable to apply the aia-900-t138 on this date due to parts availability.The fse replaced the z axis motor and verified alignments which were all within specifications.The instrument was returned to operational status.The aia-900 analyzer is functioning as expected.No further action required by field service.The part was returned to tosoh instrument service center for investigation.Physical examination of part included hand spinning the motor shaft; found two positions, approximately 90 degrees apart, where shaft would bind up, indicating a bad internal gear reducing drive.Part failed due to two separation positions causing the motor to bind.The motor failed for binding in the gears.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from (b)(6) 2019 through aware date (b)(6) 2020.There were no similar complaints identified during the searched period.The aia-900 operator's manual under section 12 flags and error messages states the following: error message: 4151 c.Trans - z home detect error cause: the home sensor s062 failed to be activated after the transfer y moved toward home position.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s062 and pm061 for a possible malfunction.Error message: 4124 sample - z bump cause: the specimen cap rear-end collision sensor s054 was activated while the specimen dispensing arm z was moving toward the home position.A ss flag will be attached to the measurement result.Action: if the cap is on the specimen, remove it and perform measurement once again.If it is not, contact tosoh local representatives.Check s054 and pm051 for a possible malfunction.The most probable cause of the reported event is failure of the stepper motor.

Event Description

Customer reported an error 4151 c trans z home detect / error 4124 sample z bump on the aia-900 analyzer.The technical support specialist (tss) advised customer to clean the sample probe and check the waste chute.When the customer rebooted the analyzer, the error occurred again.The tss also advised customer to inspect the sorter and the customer did not see anything that would imped movement.A field service engineer was dispatched to address the reported issue which caused a delay in reporting intact parathyroid hormone (ipth) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 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: 10489110
• MDR Text Key: 249834452
• Report Number: 8031673-2020-00248
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AIA-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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