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 04/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: a field service engineering (fse) was at customer's site to resolve reported event.Fse confirmed the error by reviewing the error log and reproduced error by attempting a sample run.While troubleshooting, fse noticed the rack pusher foot was out of position.Fse adjusted the home sensor flag for the x1 motor, then ran rack rotation without errors.Fse checked rack presence sensors and all was operating as expected.Fse successfully completed a daily check run without errors.Customer performed a quality control run, which passed without errors and within acceptable range.No further action required by field service.The aia-900 analyzer 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 11358105.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: [2300] s.Loader step feed failure cause: the pitch sensor s071 failed to go on after the step feed.Action: check to see if there is any impediment to the sample rack feed.If the trouble reoccurs, contact the tosoh local representatives.Check s071 and the step feed mechanism.The most probable cause of the reported event is due to misaligned x1 sensor flag.

Event Description

A customer reported getting error message "2300 sample loader step failure" at the start of a sample run on the aia-900 analyzer.The customer confirmed all set home and eject all racks operations completed successfully.Customer also stated a rack jam had occurred earlier during the previous run.Analyzer is down.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of prolactin (prl) 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: 10007935
• MDR Text Key: 222560437
• Report Number: 8031673-2020-00125
• 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
• Type of Report: Initial
• Report Date: 04/27/2020

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
• Initial Date Manufacturer Received: 04/10/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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