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 03/12/2020

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 reported errors by reviewing the error log.The problem was reproduced by attempting a diluent prime.Fse cleaned and lubricated the drive shaft for pulse motor (pm201) of the diluent syringe unit and the diluent syringe unit functioned as expected afterwards.Fse also noted the tubing for the substrate syringe had signs of leakage and replaced the tubing from top of the substrate syringe to 3-way valve for the substrate; several primes were performed, and no further signs of leakage was observed.Fse successfully validated analyzer and completed qc run; all results were within acceptable range.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 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 aia-360 operator's manual, section 7-1: list of error messages states the following: [4013] spec.Sy home not found: is generated when the home position of specimen syringe motor cannot be detected.The operator is instructed to turn the power off and on again.If this problem reoccurs, contact the service department.The most probable cause of the reported event was due to diluent syringe unit shaft for pm201 needed cleaning and lubrication.

Event Description

A customer reported getting error message "4013 specimen syringe home not found" on the aia-360 analyzer.The analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of beta human chorionic gonadotropin (bhcg), follicle stimulating hormone (fsh), luteinizing hormone (lhii) and prolactin (prl) 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 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: 9930643
• MDR Text Key: 261063986
• Report Number: 8031673-2020-00101
• 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: 03/12/2020
• Initial Date FDA Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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