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 05/21/2020

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 was able to reproduce the issue by attempting to perform a sorter cup pickup macro.Sorter alignments were performed which resolved the issue.Two-cup transfer macros were then completed without any errors.Instrument validation and quality control (qc) passed within the manufacturer's published ranges.The aia-2000 analyzer returned to operation.No further field action required.A complaint history review and service history review for similar complaints was performed for serial number (b)(4) from installed date of (b)(6) 2019 to aware date 21may2020.One other similar complaint was identified during the search period.The aia-2000 operator's manual states the following: [4053] sorter z-axis home overrun cause: the home sensor activated improperly following movement of the sorter z-axis.If retry fails, the measurement result will be flagged (mf flag).Solution: contact tosoh service center or local representatives.The probable cause of the issue is attributed to misalignment of the sorter.

Event Description

A customer reported error 4053 sorter z-axis home overrun on the aia-2000 analyzer.The customer observed multiple cups dropped in the cup pickup area.The analyzer was not in operation.A field service engineer (fse) was dispatched.A field service engineer (fse) was dispatched to address the reported issue, which resulted in the delay of reporting alpha-fetoprotein (afp) patient results.There was no report of patient intervention or adverse health consequences due to delay in reporting.

Manufacturer Narrative

Additional information: a review of the device history record (dhr) was conducted for serial number (b)(6) , 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: 10153637
• MDR Text Key: 219005414
• Report Number: 8031673-2020-00151
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• 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
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1