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 04/06/2020

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 noted the bf table was replaced recently.During the evaluation, the fse discovered the alignment of the x-axis cup transfer to the bf table had shifted.The fse reset the alignment and performed a system test.Daily check, calibration, and quality control (qc) results were within the acceptable range.The aia-2000 analyzer returned to normal operation.No further field action required.A 13-month complaint history review and service history review for similar complaints was performed for serial number (b)(4) from 06mar2019 to aware date 06apr2020.No other similar complaints were identified during the search period.The aia-2000 operator's manual states the following: [4163] x-axis cup transfer z-axis home overrun.Cause: the home sensor activated improperly after movement of the x-axis cup transfer z-axis.If this occurs, the current measurement result will be flagged (mf flag) and new measurements will be suspended.Solution: contact tosoh service center or local representatives.The probable cause of the issue is attributed to the misalignment of the x-axis cup transfer to the bf table.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

The customer reported error 4163 message after approximately fifty (50) samples on the aia-2000 analyzer.The customer noted the cup missed the incubator.A version up and cleaning had previously been performed, but the error continued.A field service engineer (fse) was dispatched to address the reported issue, which resulted in a delay reporting of follicle-stimulating hormone (fsh) test results.There was no report of patient intervention or adverse health consequences due to the 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
• 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: 10032520
• MDR Text Key: 190144267
• Report Number: 8031673-2020-00136
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• 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
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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