MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problems Suction Problem (2170); Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) followed up with the site via telephone and spoke to someone from the lab.The fse confirmed the issue with customer over the phone.Customer reported that the waste tubing was disconnected from the bf wash probe.Customer was able to resolve the issue by reconnecting the waste tubing to bf wash probe.The fse followed up with the customer a few days later and customer confirmed that the issue was resolved.The aia-360 analyzer performed as intended and returned to operation.No further action required by field service.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 11nov2019 through aware date (b)(6) 2020.There were no similar complaints identified during the search period.The aia-360 operator's manual under chapter 7- list of error messages states the following: [2016] error message: bfprobe suction failure.Description: suction by the bf probe is abnormal.Troubleshooting: contact the service department.The most probable cause of the reported event was failure of waste tubing for bf wash probe.

Event Description

Customer called on the aia-360 with a bf probe wash error 2016 on quality controls (qc).The wash and diluent was inspected and it was full and in date.The waste is half full and the customer cleaned the electrodes, all set home.The all set home resulted in bf probe suction failure error 2016.The site indicated that the bf probe was not connected.A field service engineer was dispatched to address the reported issue which caused a delay in reporting intact parathyroid hormone (ipth) patient samples.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, tokyo 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 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: 11131209
• MDR Text Key: 239812541
• Report Number: 8031673-2020-00402
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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: 12/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2004
• 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