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 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer site to address the reported issue.The fse confirmed and reproduced the reported error.The fse resolved the issue by replacing the wash probe.Multiple wash primes were then performed with no errors.Instrument validation was performed by quality control (qc).Qc results passed within the published ranges.The aia-2000 analyzer returned to operation.No further action required by field service.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 23sep2018 to aware date 23oct2019.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: [2240] b/f probe 2 purge failure.Cause: the overflow sensor failed to detect liquid even after the washer was purged.Solution: air may be trapped in the washer tubing.Purge any remaining air by performing the priming operation and check for the presence of air in the washer tubing.If retry fails, contact tosoh service center or local representatives.The probable cause of the issue is under investigation.

Event Description

A customer reported receiving error 2240 message while operating on the aia-2000 analyzer.Technical support had the customer check the bf probe for any bead blocking the tip.No bead was blocking the tip; however, the tip was replaced.The customer then performed a wash prime and the error immediately appeared.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of intact parathyroid hormone (ipth) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

• 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
• 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: 9337114
• MDR Text Key: 219774447
• Report Number: 8031673-2019-00462
• 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 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2017
• 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