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

Model Number AIA-360

Device Problem Noise, Audible (3273)

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

Event Date 07/18/2019

Event Type  malfunction  

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.Device evaluation by manufacturer: a distributor engineer visited the customer to address the reported event.The distributor engineer found the sample nozzle was bent and resolved the reported issue by replacing the sample nozzle assembly.The aia-360 analyzer was operational.There was no further action required by distributor engineer.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 similar complaints identified during the searched period.The probable cause of the reported event was due to failure of the sample nozzle.

Event Description

A customer reported loud noise coming from the aia-360 analyzer, and the analyzer will not initialize.A field service engineer (fse) was dispatched to address the reported event, which resulted in a delay of prolactin (prl) and follicle stimulating hormone (fsh) 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: 9958205
• MDR Text Key: 219156814
• Report Number: 3005529799-2020-00031
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: PM
• 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: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• 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: 02/19/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2011
• 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