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 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed the issue on the error log and replicated the issue by running a cup transfer test on the instrument.The fse resolved the issue by replacing the incubator and driver board.Instrument validation was performed via quality control (qc).Qc results passed within the published ranges.The aia-900 instrument 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 (b)(6) 2019 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.An 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.The probable cause of the issue is attributed to faulty incubator and driver board.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A customer reported error 4153 c.Trans-z home overrun on the aia-900 analyzer.An fse was dispatched.A field service engineer (fse) went onsite 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.

Manufacturer Narrative

Device evaluation: h6 the suspect incubator was returned to tosoh instrument service center for investigation.The incubator was installed on a test aia-900r instrument.During analysis, it was noted that the incubator x-axis to the cup pickup center could not be adjusted.Additionally, there was excessive slip in the turntable drive belt, inhibiting adjustment.The reported issue was replicated.The incubator failed alignment due to stretched drive belt.The suspect dvr board was returned to tosoh instrument service center for investigation.A visual inspection revealed no shipping damage.The dvr board was installed on a test unit.Functional testing was performed, and the dvr board performed as expected.The reported issue could not be replicated.The probable cause of the issue is attributed to faulty incubator.The driver board performed as expected.Additional information: d8, d9.

• 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
• MDR Report Key: 10469371
• MDR Text Key: 249862600
• Report Number: 8031673-2020-00243
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• PMA/PMN Number: K971103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1