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 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site on two separate occasions to address the reported event.On 9/16/2019.The fse was able to confirm the complaint by running get cup macro.The issue was reproduced by watching the cup fall off reagent /tip lane and resolved by replacing the sorter board, doing a tray draw alignment, and tip cup lane adjustment.On 9/18/2019, the fse was able to confirm the complaint by observing that the stc cups had fallen into stc lane from the sorter head which caused an obstruction.The issue was reproduced by running macro.The issue was resolved by replacing the pm020 x axis sorter motor.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 for similar complaints was performed for the serial number (b)(4) from 13aug2018 through aware date 13sept2019 there was one other similar complaint identified during the review period.The aia-2000 operator's manual under appendix 4: error messages states the following: 2150 - hybrid arm /cup transfer cup detection failure cause : the cup-gripping sensor failed to detect a cup before pickup.The measurement result will be flagged (mf flag or se flag).Solution : contact tosoh service center or local representatives.4121 - stc lane home detection failure cause : the home sensor failed to activate after the stc lane 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 probable cause of the reported event was due to failure of the pm020 x axis sorter motor and stc cups which had fallen within the stc lane which was caused an obstruction of movement.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported getting error messages 2150 hybrid arm/cup transfer cup intermittently and 4121 stc lane home detection failure on the aia-2000 instrument.The customer stated that the hybrid arm lane is clear and performing an all set home completes.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of beta human chorionic gonadotropin (bhcg), luteinizing hormone (lhii), progesterone (progii), follicle stimulating hormone (fsh), and prolactin (prl) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

The sorter x-axis motor (part # 020241) and sort board (part # 022234) were returned to tosoh instrument service center for investigation.Functional testing could not confirm the reported issue was due to failure of the returned parts as the error could not be duplicated.The probable cause of the reported event could not be determined.

• 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: 9158839
• MDR Text Key: 220518246
• Report Number: 8031673-2019-00389
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• 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: 09/27/2019
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1