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 03/30/2020

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 engineering (fse) was at the customer's site to address reported event.Fse confirmed and reproduced the reported error by attempting to perform an all set home function.Fse found that the main arm would not move in the y direction and resolved the issue by replacing the pmd 1 board.Fse verified all alignments successfully.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: [4211] main arm y-axis home detection failure.Cause: the home sensor failed to activate after the main 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 was due to faulty pmd 1 board.

Event Description

A customer reported getting error message "4211 main arm y-axis home detection failure" on the aia-2000 instrument.The customer inspected instrument for any obstructions or dropped tip, none was found.Customer is unable to perform an all set home function.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for estradiol (e2).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: 9986285
• MDR Text Key: 261064495
• Report Number: 8031673-2020-00117
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• 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: 022100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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