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 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the reported error on the error log in addition to error 4276 incubator positioning error; however, the errors could not be reproduced.The fse removed all testing cups from the incubator turntable and discovered serum spillage on the cup holders.The fse cleaned the incubator thoroughly with alcohol and verified alignment of all cup transfer positions by running a maintenance cup transfer test, which passed without any errors.Quality control (qc) performed passed and seventy (70) assays completed successfully.The cup transfer and turntable operated as expected.While running the assays, the fse noted error 2141 no cup from sorter occurred and returned to the site the following day to perform instrument evaluation.The fse verified the error on the error log and was able to reproduce the issue by running a maintenance sorter test.The fse found the sorter alignment was off and aligned the sorter cup positions to correct the issue.All verified vacuum suction was within specification.Additionally, three (3) sorter tests completed without any errors.Quality control and thirty-four (34) assays completed without any issues.The aia-900 analyzer returned to normal operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 06jun2019 to aware date (b)(6) 2020.Two other similar complaints were identified during the search period.The aia-900 operator's manual states the following: c.Trans-z home overrun.Cause: the home sensor s062, which is not supposed to be activated after the cup transfer z-axis moves, was activated.No further operation will take place.A mf flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s062 and also check to see the cause of slipping, and so on, that occurs when pm061 moves to the limit side.Incubator positioning error.Cause: the home sensor s120, which is supposed to detect the incubator when it reaches the target position, failed to be activated.Measurement will be interrupted.Action: please contact tosoh local representatives.Check s120 and pm120 for a possible malfunction.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.The probable cause is attributed to serum spillage on the cup holders and misalignment of the sorter alignment.

Event Description

A customer reported receiving error 4153 c.Trans-z home overrun on the aia-900 analyzer.The cup waste chute was clear, and the cup transfer assembly was cleaned.An onsite service was requested.A field service engineer (fse) was dispatched to address the reported issue, which resulted in the delay of reporting intact parathyroid hormone (ipth) patient results.There was no report of patient intervention or adverse health consequences due to 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: 10353903
• MDR Text Key: 228228920
• Report Number: 8031673-2020-00201
• 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: 07/27/2020

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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