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 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The fse confirmed the reported error by reviewing the instrument error logs.The error was reproduced by running a sorter test.While troubleshooting the fse found that the sorter needed to be adjusted to the d lane.After adjusting the sorter d lane, the fse ran the sorter test with no errors.The fse ran quality controls and results were within range per the manufacturer package insert sheet ranges.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 for similar complaints was performed for the serial number (b)(4) from 19aug2018 through aware date 19sept2019.There were no other similar complaints identified during the review period.The aia-900 operator's manual under section 12 flags and error messages states the following: 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 probable cause of the reported event was due the sorter which needed to be adjusted to the d lane.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 message 4053 sorter-z home overrun on the aia-900 instrument.The customer states that this error began occurring the previous day and occurred 9 times; the error continues to persist randomly.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of beta human chorionic gonadotropin (bhcg), and alpha-fetoprotein (afp) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• Brand Name: AIA-900
• Type of Device: AIA-900
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer (Section G): TOSOH CORPORATION (MANUFACTURER); shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: ms. oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9168331
• MDR Text Key: 220519129
• Report Number: 8031673-2019-00400
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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