MAUDE Adverse Event Report: TOSOH BIOSCIENCE, INC. AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

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

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

A distributor field service engineer (fse) was at the customer site to address the reported issue.The fse replaced the printer board to resolve the printer issue.The fse then verified the s206 sensor was clean and performed clog detection adjustment.Patient samples were processed without any issues.The aia-360 analyzer returned to operation.No further action required by field service.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4), from installation date of 11aug2018 to aware date 11sep2019.No other similar complaints were identified during the search period.The aia-360 operator's manual states the following: [4017] spec.Sy clog detected description: specimen clog was detected.Troubleshooting: the item is not assayed.Repeat assay.The probable cause of the reported issues is attributed to clog detection adjustment and faulty printer board.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported to the distributor receiving error message 4017 spec.Sy clog detected while operating on the aia-360 analyzer, and the printer was not functioning.A distributor field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of estradiol (e2) and troponin i (ctnl2) 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 BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city OH 43123
• Manufacturer Contact: bernadette o'connell ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6506368143
• MDR Report Key: 9172745
• MDR Text Key: 220519632
• Report Number: 3005529799-2019-00156
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: HO
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2017
• 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
• Patient Outcome(s): Required Intervention