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 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer's site to resolve the reported event.Fse identified the substrate line had a kink in it from being pinched.The replacement part was not available in inventory, nor was there an active part number for the part; fse requested a (substrate bottle line) be made for the aia-900 instrument.A substrate bottle line was manufactured in the tosoh instrument service center (isc) and shipped to customer's lab.The issue was resolved by replacing the substrate tubing bottle line.The instrument was validated by running a daily check and quality controls (qc).The qc results passed and were within published ranges (per package insert).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 (b)(6) 2018 through aware date (b)(6) 2019.There were no other similar complaints identified during the review period.The aia-900 operator's manual under section 6 assay preparations states the following: substrate replacement displays whether fluid replacement for the substrate tubing was sufficient.When sufficient: ok / when insufficient: ng.(if "ng" is displayed, first confirm that the remaining volume of substrate is sufficient and conduct the daily check again.) the probable cause of the reported issue was due to the substrate tubing being crimped.

Event Description

A customer reported that the substrate tubing crimped on the aia-900 instrument.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of follicle stimulating hormone (fsh) and luteinizing hormone (lh ii) 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: 9182960
• MDR Text Key: 196414021
• Report Number: 8031673-2019-00419
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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