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 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer's site to address reported event.Fse confirmed the reported error by reviewing the error log but was not able to duplicate the problem.Fse moved the y axis in both directions while in the free pulse mode, and no obstructions or rough spots was found.Fse cleaned and lubricated the hybrid arm rail, disconnected then reconnected the hybrid arm y motor connection, verified that the y-axis home sensor was properly connected, and confirmed dust was not in the sensor "ears".Fse successfully performed a daily check run without error, ran quality control without error and within acceptable range.No further action required by field service.The aia-2000 instrument 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 similar complaints identified during the search period.The aia-2000 operator's manual under appendix 4: error messages states the following: [4241] hybrid arm y-axis home detection failure cause: the home sensor failed to activate after the hybrid arm y-axis moved toward the home position.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The most probable cause of the reported event could not be reproduced.

Event Description

A customer reported getting error message "4241 hybrid arm y-axis home detection failure" on the aia-2000 instrument.The customer checked for obstructions and dropped tips/cups in the sorter tray, none was found.The customer is unable able to complete "all set home" function.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for alpha-fetoprotein (afp).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, japan 10586-23 ; JA 1058623
• MDR Report Key: 9930637
• MDR Text Key: 205686217
• Report Number: 8031673-2020-00105
• 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: 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-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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