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

Model Number AIA-360

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a distributor engineer visited the customer to address the reported event.Fse found a busted tubing and resolved the complaint by repairing the tubing.The aia-360 analyzer is operational.There was no further action required by distributor engineer.A 13-month complaint history review and service history review for similar complaints was performed serial number (b)(4).There were no similar complaints found during the searched period.The aia-360 operator's manual under chapter 2-4- installation procedure provides detailed instruction and picture diagram on tubing connections.The most probable cause of the reported event was due to an internal tubing leak.

Event Description

A customer reported getting liquid leak detected on the aia-360 analyzer.A distributor engineer was dispatched to address the reported event, which resulted in a delay of estradiol (e2), progesterone ii (prog ii), follicle stimulating hormone (fsh) and cardiac 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
• Manufacturer (Section G): TOSOH BIOSCIENCE, INC.; 3600 gantz road; grove city, oh
• Manufacturer Contact: bernadette oconnell ; 6000 shoreline court; suite 101; south san francisco, ca ; 9368143
• MDR Report Key: 9925481
• MDR Text Key: 205695013
• Report Number: 3005529799-2020-00023
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2016
• 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