MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 11/14/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the reported issue from the result printouts.The fse did not attempt to reproduce the reported complaint as this has been an intermittent ongoing issue over the last few months.The fse cleaned the diluent/wash tower and primed the diluent and observed the flow.The flow appeared to be slow and weak.The fse replaced the liquid (diluent) pump.The fse ran a daily check and quality control (qc) with no errors and the results were within specifications.The aia-360 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review for similar complaints were performed for serial number (b)(4) from (b)(6) 2019 through aware date (b)(6) 2020.There were no similar complaints identified during the search period the aia-360 operator's manual under section 7-1: list of error messages states the following: [2012] error message: air detected diluent description: there is no contact with the liquid after diluent suction.Troubleshooting: contact the service department.The most probable cause of the reported event was due to a faulty liquid (diluent/wash) pump.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer called report an error 2012, air detected diluent error on the aia-360 analyzer.Customer indicated that this has been happening intermittently over the last few months.Customer stated that she has replaced the wash and diluent caps recently, although the technical support specialist (tss) found no calls for this error.The tss advised customer to clean the contacts for the wires to the cap.Customer also checked for broken wires.Customer then performed a couple of diluent primes which passed without error.Customer then tried to run a few samples and the error occurred on two out of three of the samples.The field service engineer (fse) 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 oconell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 11002449
• MDR Text Key: 222039336
• Report Number: 8031673-2020-00366
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• 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: 11/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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