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 10/23/2019

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 a run.Fse found the dispense lane was out of adjustment, adjusted the dispense lane, then made adjustments from the sorter to the dispense lane, adjusted the seal break position, and adjusted the cup transfer positions at the dispense lane.The fse also adjusted the incubator in and out positions, removed and cleaned the incubator and lubricated the bearings with tri-flow.Fse successfully performed a daily check run, attempted qc runs but they were aborted with 4153 "c.Trans-z home overrun "and 2161 "c.Transfer cup pickup failure "errors.Fse was unable to return instrument to service.Fse ordered parts for instrument repair and returned to customer's site when parts were received.Fse returned to customer's site and was able to reproduce the 4153 error.The fse also observed a short test of qc samples of which the cup transfer assembly would crash into the incubator on the 5th cup transfer.The customer had disposed of the black test cup adapters and so the fse could not perform a cup transfer test run.The fse also observed that the table or carousel of the incubator had quite a bit of slip while in position.Additionally, the cup transfer assembly had noticeable damage to the claws which caused it to open unevenly when picking/putting test cups.Fse replaced both the incubator and cup transfer assembly and re-aligned all movements.Fse successfully completed 15 replicates of qc samples without error.Instrument was validated by running two levels of qc without errors and within acceptable 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 through aware date of event for similar complaints was performed for serial number (b)(4).There were two (2) similar complaints identified during the searched period, which includes this event.The aia-900 operator's manual under section 12 - flags and error messages states: [4053] sorter-z home overrun cause: the home sensor s022, which is not supposed to be activated after the sorter z-axis moves, was activated.A retry will take place, and if there is no improvement a flag will be attached to the measurement result.Action: please contact tosoh local representatives.Check s022 and also check to see the cause of slipping, and so on, that occurs when pm022 moves to the limit side.[4153] 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.[2161] c.Transfer cup pickup failure cause: the cup sensor s063 failed to detect the cup after the cup was grasped.Action: please contact the tosoh local representatives.Check s063, the cup pickup position, and the cup pickup operation.The incubator assembly and cup transfer assembly were returned to tosoh instrument service center for investigation.Visual inspection confirmed both parts were damaged.The most probable cause of the reported event is due to damaged incubator assembly and cup transfer assembly.

Event Description

A customer reported getting error message "4053 sorter-z home overrun" on the aia-900 instrument.Technical support specialist (tss) instructed the customer to open and close the sorter, check for dropped cups or tips near the incubator and around the sampling arm, and check to make sure waste is not backed up.The customer then attempted a sample run, but error reoccurred after instrument warmup.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of beta human chorionic gonadotropin (bhcg) and cardiac troponin i (ctnl2) 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: 9336557
• MDR Text Key: 194331762
• Report Number: 8031673-2019-00463
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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