MAUDE Adverse Event Report: TOSOH CORPORATION AIA-360

Model Number AIA-360

Device Problem Mechanical Problem (1384)

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

Event Date 10/28/2019

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 problem by checking the error log and found the problem to be intermittent with the frequency of the error increasing.The fse was unable to reproduce the problem by initializing the instrument.The substrate dispenser, substrate syringe assembly, detector and alignment of the detector was checked.The fse found that the sv501 3-way valve for the substrate delivery showed evidence of leakage.The 3-way valve for the substrate delivery was replaced.The instrument was validated by running quality controls (qc).The qc results passed and were within manufacturer ranges.No further action required by field service.The aia-360 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 28sept2018 through aware date 28oct2019.There was one other similar complaint identified during the review period.The aia-360 operator's manual under section 7-2: list of flags states the following: flag: meaning: insufficient substrate dispensing volume or low detector light intensity.Action: perform assay, cal: reject, result: rate.Dl - the substrate dispensing amount is less than the specified amount or the lamp intensity of the fluorescence is low.If the dl flag is attached, replace the substrate (mainte screen - 6 replace substrate check ok) and repeat assay.If the dl flag appears again contact the service department.The probable cause of the reported event was due to the sv501 3-way valve for the substrate which showed evidence of leaking.

Event Description

A customer reported getting multiple dl flags on the aia-360 instrument during the day.This issue began occurring about one month ago and now the issue is increasing in frequency.Most recently the dl flag occurred, and the substrate was just one day old.The customer checked to verify that the substrate straw is not occluded by the bottle.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of 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-360
• Type of Device: AIA-360
• 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: 9380185
• MDR Text Key: 219773271
• Report Number: 8031673-2019-00473
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-360
• Device Catalogue Number: 019945
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• 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