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

Model Number AIA-360

Device Problem Electrical Power Problem (2925)

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

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a distributor engineer visited the customer to address the reported event.The reported issue was resolved by replacing the power supply.No further action required by field service.The aia-360 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed serial number (b)(4) from 07-sep-2018 through aware date of 07-oct-2019.There were no similar complaints found during the searched period.The aia-360 operator's manual under chapter 2-2 - 2-5: installation environment & power supply provides detailed information on proper installation procedure and system power supply specifications.The most probable cause of the reported event was due to damaged external power source to the analyzer.

Event Description

A customer reported the aia-360 analyzer will not turn on.The customer stated no voltage on the power board.A distributor engineer was dispatched to address the reported event, which resulted in a delay of luteinizing hormone (lhii) 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 oconnell ; 6000 shoreline court; suite 101; south san francisco, CA 94080 ; 6509368143
• MDR Report Key: 9216249
• MDR Text Key: 217359199
• Report Number: 3005529799-2019-00158
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2015
• 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