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 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was at customer site to address the reported event.The complaint was confirmed by review of error log.The issue was with all 4 bf probes.The fse performed an analog board sensitivity adjustment for all bf probes and verified proper operation by performing the wash prime several times.The instrument was validated by running controls.The quality controls (qc) passed and were within published package insert ranges.The instrument met performance requirements after service.No further action required by field service.The aia-2000st instrument is functioning as expected.The aia-2000st, serial number (b)(4), was installed at the account on 24jul2019.A complaint history review and service history review for similar complaints was performed from 24jul2019 through aware date (b)(6) 2019.There were no other complaints identified during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: 2242 - b/f probe 4 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 reported event was due to the bf probes which needed a sensitivity adjustment.

Event Description

A customer reported getting error message 2242 b/f probe 4 purge failure on bf probes 1, 2 and 4 with the aia-2000st instrument.The customer stated that the instrument was rebooted, the tips were on and clean, the sensor was cleaned, and there were no obvious leaks.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting of alpha-fetoprotein (afp) patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.

Manufacturer Narrative

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.

• 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: 9268434
• MDR Text Key: 220572638
• Report Number: 8031673-2019-00417
• 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: 12/04/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1