MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-2000

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was able to confirm the error by reviewing the error log.The fse also reproduced the error by observing the bf wash probe number one while priming not suctioning all of the wash from the wash well.The fse investigated the error and found out that the bf wash probe number one was clogged not allowing it to suction wash properly, most likely caused by magnetic beads being clogged inside the bf wash probe number one.The fse replaced the bf wash probe number one and verified alignments within specification.The fse ran wash prime and daily check without error returning.Customer ran quality control (qc) and the analyzer was operating as expected.Customer returned the analyzer to normal operation.The aia-2000 analyzer is functioning as expected.No further action required by field service.A 13-month complaint history review and service history review for similar complaints were performed for the serial number (b)(4) from 03mar2019 through aware date of (b)(6)2020.There were no similar complaints identified during the searched period.The aia-2000 operator's manual under appendix 4: error messages states the following: error message: [2235] b/f probe 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 this reported event was a clogged wash probe number one.

Event Description

Customer reported an error 2235 b/f probe 1 suction failure error.The decontamination was performed the other night.Customer also added that they were able to run a few specimens after the decontamination.A new bf probe tip was installed and the wash reagent was replaced and both tubing to the wash probe was connected.A field service engineer was dispatched to address the reported issue which caused a delay in reporting alpha-fetoprotein (afp) patient samples.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.

• 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
• Manufacturer (Section G): TOSOH CORPORATION; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586 23; JA 1058623
• Manufacturer Contact: bernadette oconnell ; shiba-koen first building; 3-8-2 shiba; minato-ku, tokyo 10586-23 ; JA 1058623
• MDR Report Key: 10550058
• MDR Text Key: 229282560
• Report Number: 8031673-2020-00260
• 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: 09/17/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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