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 03/13/2020

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 engineer (fse) was at the customer's site to address reported event.Fse confirmed the reported error by running a sample test run and also noted error 2060 "tip attachment failure by main arm" had also occurred.While troubleshooting, fse verified tip alignments were good and replaced the sample nozzle, but error persisted.Fse resolved the issue by replacing the eki board.The level detect function parameters were adjusted and tested by running samples.Fse successfully ran daily check and quality control runs without errors 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 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: tip detachment failure by main arm.Cause: a tip was detected by tip detachment check.If retry fails, the measurement result will be flagged.(mf flag).Solution: contact tosoh service center or local representatives.Tip attachment failure by main arm.Cause: no tip was detected by tip attachment check.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 failure of eki board.

Event Description

A customer reported getting error message "2061 tip detachment failure by main arm" on the aia-2000 instrument.The customer rebooted instrument and performed a version up, but error persisted.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for follicle stimulating hormone (fsh).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

The eki board and sample nozzle were returned to tosoh instrument service center for investigation.The shield wire of the sample nozzle was frayed causing bad connection to eki board.Functional testing confirmed the reported failure of the eki board and sample nozzle.The most probable cause of the reported event was due to failure of eki board and sample nozzle.

Event Description

N/a.

• 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
• MDR Report Key: 9930640
• MDR Text Key: 228350110
• Report Number: 8031673-2020-00098
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1