MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/17/2020

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.Device evaluation by manufacturer: a distributor engineer visited the customer's site to address the reported issue.Fse performed maintenance to the waste pump, and confirmed it was functioning properly.Fse also shut down the analyzer, cleaned, and dried the area of the analyzer.The customer successfully performed quality control (qc) without any errors.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 aia-360 operator's manual under section 7-1 list of error messages states the following: leak sensor s702 detected is generated when the leakage sensor s702 activated.The operator is instructed to contact the service department.The most probable cause of the reported event was due to waste pump needed maintenance.

Event Description

A customer reported getting error message "3022 leak sensor s702 detected" on the aia-360 analyzer.A distributor engineer instructed the customer to take the upper and back cover of the analyzer off, and inspect the s702 sensor, customer confirmed leakage in the sensor area.A distributor engineer was dispatched to address the reported event, which resulted in delayed reporting of patient results for alpha-fetoprotein (afp), prolactin (prl), and progesterone (prog ii).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: 10568099
• MDR Text Key: 208144245
• Report Number: 8031673-2020-00271
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: CJ
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2017
• 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