MAUDE Adverse Event Report: TOSOH CORPORATION AIA-900

Model Number AIA-900

Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Noise, Audible (3273)

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

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineering (fse) was at customer's site to resolve reported event.Fse confirmed the reported error by reviewing the error log.Fse reproduced the problem by attempting to initialize instrument and error occurred.Upon further troubleshooting, fse removed the instrument covers and found a dropped cup had blocked the d lane from getting to the home position.Fse removed the cup and attempted to initialize, but the home sensor did not sense the d lane home.Fse adjusted the sensor and performed all d lane adjustments; then rebooted and initialized properly without error.Fse attempted a qc run but error 2141 "no cup from sorter" occurred after hearing the d lane hit the right-side wall.Fse removed and inspected the seal breaker, performed alignments for seal breaker, verifying s041 led lit properly and found no issues.Fse cleaned both s030 and s032 sensors, ran seal break x10 test two times with good piercing and no errors.Fse completed sample run without error, validated instrument by running qc; results were without errors and within acceptable range.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 through aware date of event for similar complaints was performed for serial number (b)(4).There were no other similar complaints found during the searched period.The aia-900 operator's manual under section 12 - flags and error messages states: [2141] no cup from sorter.Cause: the cup sensor s032 did not detect the cup which entered the dispensing lane from the sorter.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: please contact the tosoh local representatives.Check s032, the position where the cup is transferred from the sorter to the dispensing lane, the cup sensing position, and the cup release operation.[4081] d.Lane-x home not detected.Cause: the home sensor s030 failed to be activated after the dispensing lane moved toward the home position.A retry will take place, and if there is no improvement a mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s030 and pm030 for a possible malfunction.The most probable cause of the reported event is due to dropped cup caused sensor mis-alignment.

Event Description

A customer reported getting error message "4081 dispense lane x home not detected" and loud grinding noise on the aia-900 instrument.Technical support specialist (tss) instructed the customer to reboot instrument, but the error and loud grinding noise persisted.Instrument is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of estradiol (e2) 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; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9297708
• MDR Text Key: 220346499
• Report Number: 8031673-2019-00445
• 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: 11/08/2019

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: 10/15/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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