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 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The fse confirmed the error by reviewing the error logs.The fse ran a sample rack and observed the instrument initially moved the rack a few steps before erroring.The fse then observed that the s072 sensor was permanently lit up.After making rough adjustments to the flag, the fse realized that the flag was still too high for the optical sensor.Further, the nut that holds the fine adjustment screw in place was loose.The issue was resolved by aligning the flag correctly in s072 sensor and then tightening the nut holding the screw to prevent the screw from loosening.The fse ran multiple racks through the instrument to ensure the screw did not move due to vibration.The instrument was validated by running two levels of quality controls (qc); the qc passed and were within published 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 10nov2018 through aware date (b)(6) 2019.There was one other similar complaint identified during the review period.The aia-900 operator's manual under section 12 flags and error messages states the following: 2301- sample rack not moved.Cause: the rack feed detection sensor s072 failed to detect rack movement when step (x1) feed took place.Action: check the direction of the sample rack and also whether or not there are any obstacles.If the trouble reoccurs, contact the tosoh local representatives.Check s072 and the step feed mechanism.2302 - s.Rack not moved completely.Cause: the rack feed sensor s072 failed to go off when step (x1) feed took place.Action: check to see if there is any impediment to the sample rack feed.If the trouble reoccurs, contact the tosoh local representatives.Check s072, the step feed position, and the step feed mechanism.The probable cause of the reported event was due to the misalignment of s072 sensor fine adjustment screw.

Event Description

A customer reported getting error message 2302 sample rack not moved completely on the aia-900 instrument.The fse was onsite the previous week to address a similar error; 2301 sample rack not moved.The customer ran an all set home, removed the rack, and repowered the instrument; the rack stopped at the same position once the rack moved about 4 positions in.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of cardiac troponin i (ctnl 2), and creatine kinase mb isoenzyme (ck-mb) 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: 9520206
• MDR Text Key: 194198973
• Report Number: 8031673-2019-00529
• 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: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: 12/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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