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 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the error on the error logs and reproduced the issue.Further troubleshooting revealed a loose screw to the z-motor which caused the cup transfer not to move.The fse secured the screw and resolved the issue.Controls were run successfully and results were within the manufacturer specifications.The aia-900 analyzer returned to operation.No further action required by field service.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 11sep2018 to aware date 11oct2019.No other similar complaints were identified during the search period.The aia-900 operator's manual states the following: [4151] c.Trans-z home detector error.Cause: the home sensor s062 failed to be activated after the transfer y 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 s062 and pm061 for a possible malfunction.The probable cause of the reported issue is due to a loose screw to the z-motor.

Event Description

A customer reported receiving 4151 c.Trans-z home detect error message while operating on the aia-900 analyzer.The customer was analyzing controls when the error occurred.Technical support had the customer perform an all set home function, but the error remained.The customer removed the analyzer cover and discovered a dropped cup and removed the cup then performed an all set home, but the error persisted.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of intact parathyroid hormone (ipth) 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 o'connell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 9291137
• MDR Text Key: 220346197
• Report Number: 8031673-2019-00432
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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