MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2019

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 and reproduced the error by performing a startup.Fse resolved the complaint by making an alignment adjustment to the main arm.Fse validated instrument by running qc, which completed without errors, and within acceptable range.No further action required by field service.The aia-2000 analyzer is functioning as expected.The aia-2000, serial number (b)(4), was installed on (b)(6) 2019.A complaint history review and service history review for similar complaints was performed from installation date (b)(6) 2019 through aware date (b)(6)2019.There were no other similar complaints identified during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: [4224] interference of dispensing nozzle z-axis of main arm cause: there is a possibility that the dispensing nozzle was interfered with an obstacle such as cap of primary tube.The measurement result will be flagged with the ss flag.Or a command or adjustment value (p05, 191-210) was given for movement beyond the maximum movable distance of the main arm z-axis in the maintenance operation.Solution: remove an obstacle such as cap of primary tube, if any.The most probable cause of the reported event was due to misaligned main arm.

Event Description

A customer reported getting error message "4224 main arm z axis limit overrun" on the aia-2000 analyzer.The customer removed the racks, performed an all set home and then powered down the analyzer, removed the tube cap but no obvious arm obstruction was found.Analyzer was rebooted, but errors reoccurred when customer attempted a daily check run.The customer confirmed the waste chute was a quarter full; technical support specialist (tss) instructed the customer to clean the main arm and rail.A field service engineer was dispatched to address the reported event, which resulted in delayed reporting of patient samples for intact parathyroid hormone (ipth).There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

Manufacturer Narrative

Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.Device evaluation by manufacturer: a review of the device history record (dhr) was conducted for serial number (b)(4), which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.

Event Description

N/a.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, 10586 23; JA 1058623
• MDR Report Key: 9263955
• MDR Text Key: 219201764
• Report Number: 8031673-2019-00414
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-2000
• Device Catalogue Number: 022100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1