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 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed error message 2062 specimen level detection failure by main arm on the error log and noted multiple errors on the main arm for level sense.The fse was able to reproduce the issue when attempting to process patient samples.Further troubleshooting revealed a bent tube sensor.The fse adjusted the sensor to the correct position and resolved the issue.The same samples were reanalyzed with no errors.Quality control (qc) results passed within the published ranges.The aia-2000 analyzer returned to operation.No further action required by field service.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from installation date (b)(6) 2019 to aware date 21oct2019.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: [2062] specimen level detection failure by main arm cause: no liquid level was detected even after the specimen dispensing tip was lowered to the bottom of the container.The measurement result will be flagged (ss flag).Solution: verify that the specimen is in the correct position and its volume is sufficient.If retry fails, contact tosoh service center or local representatives.Monitoring: this error occurs when the conditions expressed by the following formula are not satisfied for three consecutive attempts when the specimen dispensing tip is lowered to 1 mm from the bottom of the container.[formula] level ad value 9 points earlier - current ad value > p10 threshold value % for individual container x (level ad value before measurement start - p10 hand touch ad value) / 100.Check: specimen volume, presence of specimen container, s150/s151 - slif board - main board, maxiaconst.Ini file p05/p10 command, probe s123 - s-eki board - s-samp board - anlg board - slv#3-4 board.The probable cause of the issue is attributed to a bent tube sensor.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 message 2062 with short sample (ss) flags while operating on the aia-2000 analyzer.The customer requested service to adjust the sampler.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of troponin i (ctnl2) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

Additional information: a review of the device history record (dhr) was conducted for serial number (b)(6).During the manufacturing process, tosoh bioscience japan discovered a rusted bf probe.The bf probe was replaced and manufacturing tests continued through completion.

• 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: 9336494
• MDR Text Key: 194330087
• Report Number: 8031673-2019-00459
• 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: 04/03/2020

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-2000
• Device Catalogue Number: 022100
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1