MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at customer's site to resolve reported event.Fse confirmed the reported error by reviewing the error log and reproduced the error by attempting to run a test cup transfer evaluation.The fse cleaned the cup pickup sensor on the hybrid arm and the main arm nozzle which was clogged.Fse also cleaned and calibrated the pressure sensor.Fse validated the analyzer by running quality control and patient samples without errors and within acceptable range.No further action required by field service.The aia-2000 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-2000 operator's manual under appendix 4: error messages states the following: [2151] hybrid arm /cup transfer cup pickup failure.Cause: the cup-gripping sensor failed to detect a cup after the cup pickup operation was performed.Solution: contact tosoh service center or local representatives.The most probable cause of the reported event was due to dirty cup pickup sensor on the hybrid arm, dirty pressure sensor and clogged main arm nozzle.

Event Description

A customer reported getting error message "2151 hybrid arm /cup transfer cup pickup failure" during a sample run on the aia-2000 analyzer.The customer stated the sample run was aborted.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for intact parathyroid hormone (ipth) and luteinizing hormone (lhii).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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, 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: 9307616
• MDR Text Key: 220346297
• Report Number: 8031673-2019-00448
• 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: 11/11/2019

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-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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