MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. AIA 2000

Model Number AIA 2000

Device Problem Mechanical Problem (1384)

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

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineering (fse) was at the customer's site to address reported event.Fse confirmed error by reviewing error logs.Fse primed the wash probe 2 several times without errors.Fse cleaned lead screw for bf wash 2 and replaced cable for bf wash probe 2 motor, cleaned lead screw for wash syringe 2, then attempted a prime wash but error 4381 occurred.Fse replaced bf washer assembly and slave board 5-6 but error persisted.Fse replaced the driver 1 board and error continued, then the wash syringe 2 assembly was replaced, which resolved the problem.Fse successfully performed quality control without errors.No further action required by field service.The aia-2000 instrument 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 no other similar complaints found during the searched period.The aia-2000 operator's manual under appendix 4 - error messages, states the following: [4381] wash syringe 2 home detection failure.Cause: the home sensor failed to activate after the wash syringe 2 moved toward the home position.The measurement result will be flagged (wu flag).Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to faulty wash syringe 2 assembly.

Event Description

A customer reported getting error message "4381 wash syringe 2 home detection failure" on the aia-2000 instrument.The customer stated they are unable to prime the instrument, instrument is down.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for intact parathyroid hormone (ipth).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

The slave 5-6 board, drive (b)(4) board, wash probe (b)(4) pulse motor assy, wash probe (b)(4) pulse motor cable, wash syringe assy were returned to tosoh instrument service center for investigation.Functional testing could not confirm the reported failure.The most probable cause of the reported event could not be duplicated.

Event Description

N/a.

• Brand Name: AIA 2000
• Type of Device: AIA 2000
• Manufacturer (Section D): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city, oh
• MDR Report Key: 10171917
• MDR Text Key: 238566794
• Report Number: 3005529799-2020-00043
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA 2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Date Manufacturer Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1