MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Pressure Problem (3012)

Patient Problem Missing Value Reason (3192)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The error was confirmed on the error log.The fse lubricated the main arm sampling assembly and resolved the issue.The aia-2000 analyzer returned to normal operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 24may2019 to aware date (b)(6) 2020.One other similar complaint was identified during the search period.The aia-2000 operator's manual states the following: [2086] abnormal pressure detected during specimen suction by main arm cause: abnormal pressure was detected during specimen suction, possibly due to the following causes: (1) the specimen has high viscosity.(2) a half-solid substance floating in the specimen, such as fibrin, was ingested.(3) air was ingested.Measuring operation is resumed and the measurement result will be flagged (uc flag).Solution: verify that the specimen is free of solid substances (such as fibrin) or bubbles on the surface and retry the measurement.If the error persists but the result is judged normal, the specimen viscosity may be high.In this case, the uc flag attached to the result can be deleted later.If the error still cannot be solved, contact tosoh service center or local representatives.Se flag: operator terminated operation or system error the probable cause of the issue was the main arm sampling assembly required lubrication.

Event Description

A customer reported error 2086 abnormal pressure detected during specimen suction by main arm on quality control (qc) material and patient samples using the aia-2000 analyzer.The customer used a stylet to clean the sample nozzle; however, the error persisted.An se system flag was noted.A field service engineer (fse) was dispatched.A field service engineer (fse) was dispatched to address the reported issue, which resulted in the delay of reporting intact parathyroid hormone (ipth) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• 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, tokyo 10586 23; JA 1058623
• Manufacturer Contact: bernadette o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10251891
• MDR Text Key: 229186800
• Report Number: 8031673-2020-00187
• 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: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000
• Device Catalogue Number: 022101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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