MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

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

Event Date 03/10/2020

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.A field service engineer (fse) was at the customer's site to address the reported issue.Fse confirmed the nozzle (needle) was bent.Fse replaced the nozzle and performed adjustments.The customer successfully performed quality control (qc); results passed within the acceptable range.The aia-360 analyzer returned to operation.No further action required by field service.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 other similar complaints found during the searched period.The most probable cause of the reported event was due to damaged sample nozzle.

Event Description

A customer reported a bent sample probe on the aia-360 analyzer.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient results for cardiac troponin i (ctnl2).There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• Brand Name: AIA-360
• Type of Device: AIA-360
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9930636
• MDR Text Key: 261066089
• Report Number: 8031673-2020-00096
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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