MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

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

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the error on the error log and was able to reproduce the issue by attempting to detach a tip.The fse removed the waste chute assembly and observed tips were jammed between the assembly housing.This was causing the instrument to "bump" in the z-axis when trying to shuck tips.The fse removed the old tips and correctly aligned the waste chute assembly and housing.Quality control (qc) was performed, and the analyzer operated normally.The aia-900 analyzer returned to operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from (b)(6) 2019 to aware date (b)(6) 2020.One other similar complaint was identified during the search period.The aia-900 operator's manual states the following: 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.An 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 probable cause of the issue is attributed to misalignment of the waste chute.

Event Description

A customer reported error 4124 sample-z bump and could not clear the waste chute on the aia-900 analyzer.The customer later stated that the waste chute was cleared but the tips were stuck inside.The chute was recently cleaned during a pm procedure.A field service engineer (fse) was dispatched.A field service engineer (fse) was dispatched to address the reported issue, which resulted in the delay of reporting follicle-stimulating hormone (fsh) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city, oh
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city, oh
• Manufacturer Contact: bernadette o'connell ; 6000 shoreline court; suite 101; south san francisco, ca ; 6368143
• MDR Report Key: 10153604
• MDR Text Key: 195120062
• Report Number: 3005529799-2020-00042
• 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: 06/12/2020

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-900
• Device Catalogue Number: 022930111
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2017
• 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