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 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The fse was able to confirm the complaint by reviewing the error logs as well as trying to run a liquid sense test.The specimen nozzle would not contact the liquid which was causing the error.The issue was resolved by adjusting the parameters for the test cup, tube, small bottle, large glass bottle, and large plastic bottle.These adjustments were verified by running the liquid sense test.The instrument software was upgraded to v2.54 per tech bulletin t121e.No further action required by field service.The aia-900 instrument is functioning as expected.The aia-900, serial number (b)(4), was installed at the account on (b)(6) 2018.A complaint history review and service history review for similar complaints was performed from (b)(6) 2018through aware date (b)(6) 2019.There were no other complaints identified during the searched period.The aia-900 operator's manual under section 12 flags and error messages states the following: 2094 - specimen shortage detected.Cause: it was judged from the remaining quantity of a rack id, rack, position, specimen id specimen that sampling of the specimen was impossible.An ss flag will be attached to the assay result.Action: replenish the specimen and perform measurement once again.If it is considered that there is a sufficient quantity of specimen, check the position setting of the bottom of the specimen container.In the case of the primary tube, check the container shape setting and also the liquid level detection sensitivity.The probable cause of the reported event was due to an incorrect parameter setting for the sampling arm.

Event Description

A customer reported getting error message 2094 specimen shortage detected on the aia-900 instrument while attempting to calibrate.As the tip goes down into the cup the error occurs right away although the test cup is full.This was the first time the customer has used the instrument since its preventative maintenance service.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of estradiol (e2), and follicle stimulating hormone (fsh) 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: 9168332
• MDR Text Key: 216649953
• Report Number: 8031673-2019-00392
• 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

• 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
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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