MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

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

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at the customer's site to address the reported issue.The fse confirmed the issue on the error log and was able to reproduce the error by performing wash prime and noted b/f (bound free) probe 1 did not evacuate the wash well after purge.The fse removed b/f probe 1 and 2 and performed prime wash and verified that b/f probe 1 was not evacuating liquid after purge.The fse switched the fluid fittings from b/f probe 1 to b/f probe 2 with the 2-way solenoid valves and noted the fault moved to b/f probe 2; the fse replaced the 2-way solenoid valve.The fse performed several wash primes and completed daily check with no issues or errors.Analyzer validation was performed through completing quality control (qc).Qc results passed within the manufacturer's published specifications.The aia-2000 analyzer conformed to the manufacturer's performance specifications and 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 10mar2018 to aware date 10apr2019.One other similar complaint was identified during the search period.The aia-2000 operator's manual, section appendix 4: error messages, states the following: [2235] b/f probe 1 suction failure.Cause: the overflow sensor detected liquid after washer suction action was completed.The measurement result will be flagged (wu flag).Solution : clean b/f probe 1.(see chapter 9, "maintenance") if retry fails, contact tosoh service center or local representatives.The most probable cause of the reported issue is attributed to the faulty 2-way solenoid valve.

Event Description

A customer reported getting system error 2235, b/f (bound free) probe 1 suction failure on the aia-2000 analyzer.The customer replaced the tip on the b/f probe, but the error persisted.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.

Manufacturer Narrative

Device evaluation: the suspect 3-way and 2-way solenoid valves were returned to tosoh bioscience for evaluation.A visual inspection revealed no shipping damage.Functional testing was performed on the 3-way solenoid valve by priming the wash solution several times.The prime completed successfully each time.The 3-way solenoid valve performed as specified.The issue could not be duplicated.Functional testing was performed on the 2-way solenoid valve by priming the wash solution several times and error message 2235 b/f probe 1 suction failure displayed.Functional testing confirmed the issue was due to a faulty 2-way solenoid valve; the valve would not open or close.

• Brand Name: AIA-2000
• Type of Device: AIA-2000
• Manufacturer (Section D): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• MDR Report Key: 8574847
• MDR Text Key: 151937604
• Report Number: 8031673-2019-00149
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1