MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

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

Event Date 11/10/2020

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 field service engineering (fse) was at the customer's site to address reported event.Fse confirmed reported error by reviewing printouts and was unable to reproduce error.Fse resolved the complaint by cleaning off the hybrid arm rail and performed a version up.Fse validated instrument by successfully completing quality control run without error and results were 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 two (2) similar complaints identified during the searched period, which includes this event.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 was due to dirty hybrid arm rail.

Event Description

A customer reported getting error message "4241 hybrid arm y-axis home detection failure" on the aia-2000 instrument.The customer performed an all set home function and rebooted instrument, but error persisted.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: 10972331
• MDR Text Key: 220972109
• Report Number: 8031673-2020-00362
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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