MAUDE Adverse Event Report: TOSOH CORPORATION AIA-2000

Model Number AIA-200

Device Problem Material Deformation (2976)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) conducted a site visit and was unable to confirm the reported issue by observing the bf wash probe 3.The fse was unable to reproduce the reported issue due to the visible damage to the probe.The fse resolved the issue by replacing the bf wash probe 3.The fse validated the instrument by performing quality control (qc).The qc results passed and was within published ranges.The instrument was returned to operational status.The aia-2000 analyzer is functioning as expected.No further action required by field service.A complaint and service history review for serial number (b)(4) from installation date of 14may2020 through aware date of 14jun2021 was performed for similar complaints.There were no similar complaints identified during the search period.The most probable cause of the reported event was failure of wash probe or ptfe tip.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

Customer contacted the field service engineer (fse) reporting a damaged bf wash probe.Customer indicated that the bf probe tip fell off and that the new probe tips will not stay attached.The field service engineer (fse) 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: 12159360
• MDR Text Key: 261258540
• Report Number: 8031673-2021-00211
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIA-200
• Device Catalogue Number: 022101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2009
• 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