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 engineer (fse) was at the customer site to address the reported issue.The fse confirmed the error on the error log and reproduced the issue.The fse inspected the bf probe and tubing to the 2-way valve and noted no anomalies.As part of troubleshooting, the fse replaced the 2-way valve but the issue persisted.The fse then replaced the lp311 waste pump and resolved the issue.Several cycles of wash prime were performed without 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 13-month complaint history review and service history review for similar complaints was performed for serial number: (b)(4), from 02sep2018 to aware date 02oct2019.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: [2238] b/f probe 4 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 4 (see chapter 9, "maintenance").If retry fails, contact tosoh service center or local representatives.The probable cause of the issue is attributed to a faulty waste pump.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 receiving error message 2238 b/f probe 4 suction failure while operating on the aia-2000 analyzer.Priming was performed, but the error returned during testing of a sample.A field service engineer (fse) was dispatched to address the reported issue, which resulted in delayed reporting of luteinizing hormone ii (lh ii) and 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: 9256372
• MDR Text Key: 219163712
• Report Number: 8031673-2019-00413
• 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: 10/30/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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