MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2019

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 customer's site to resolve reported event.Fse confirmed the reported error by reviewing the error log.While troubleshooting, the fse ran the sorter test from the maintenance menu and observed the alignments were off to random positions.Fse performed alignments, but the sorter was still mis-aligned on some cups.Fse resolved the problem by exchanging the sort board and verified the replacement by running the sorter test.Fse validated the instrument by running qc; results were without errors and within acceptable range.No further action required by field service.The aia-900 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-900 operator's manual under section 12 - flags and error messages states: [4053] sorter-z home overrun cause: the home sensor s022, which is not supposed to be activated after the sorter z-axis moves, was activated.A retry will take place, and if there is no improvement a flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s022 and also check to see the cause of slipping, and so on, that occurs when pm022 moves to the limit side.The most probable cause of the reported event is due to faulty sort board.

Event Description

A customer reported getting error message "4053 sorter z home overrun" during quality control run on the aia-900 instrument.The instrument is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of beta human chorionic gonadotropin (bhcg) and cardiac troponin i (ctnl2) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Event Description

N/a.

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.The sort board was returned to tosoh instrument service center for investigation.Functional testing could not confirm the reported failure of the sort board.The most probable cause of the reported event is unknown.

Manufacturer Narrative

Correction: h10.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(6) from 27oct2018 through aware date 27nov2019.There were three (3) other similar complaints identified during the searched period, which includes this event.

• Brand Name: AIA-900
• Type of Device: 0
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 9513453
• MDR Text Key: 194146293
• Report Number: 8031673-2019-00515
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-900
• Device Catalogue Number: 022930111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Date Manufacturer Received: 06/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1