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 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a distributor engineer visited the customer to address the reported event.The distributor engineer found the home sensor of the sorter was dirty.Fse resolved the complaint by cleaning the sensor.The aia-900 analyzer is operational.There was no further action required by distributor engineer.A 13-month complaint history review and service history review and keyword search for similar complaints was performed for aia-900, serial number (b)(4).There were two (2) similar complaints identified during the searched period, which includes this event.The aia-900 operator's manual under section 11 - maintenance provides detailed information on analyzer maintenance.The most probable cause of the reported event was due to dirty sorter home sensor.

Event Description

A customer reported getting the home sensor of the sorter was not found failure on the aia-900 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 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 oconnell ; 6000 shoreline court; suite 101; south san francisco, ca ; 9368143
• MDR Report Key: 9930538
• MDR Text Key: 207794095
• Report Number: 3005529799-2020-00021
• 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: 04/06/2020
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2017
• 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