MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN RUBY SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number 08H67-01

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information is included.Additional patient details are not available.

Event Description

The customer reported while completing a flow cell rinse on the cell-dyn ruby analyzer, as instructed by an abbott representative in association with ticket # (b)(4), a colleague was splashed with the hypochlorite solution she was using.The reporter explained; she was using a syringe with a peristatic tubing as an adapter to clean the flow cell, when the fitting that connects the tubing to the instrument popped off and hypochlorite solution splashed out of the syringe into the room.A colleague was walking by and the hypochlorite splashed onto her forehead, temple and next to her eye.She immediately washed her face.No fluid got into the eye.There was no open skin.There was no treatment required beyond face washing.There was no impact to patient management reported.

Manufacturer Narrative

Health effect impact code: f26.Component code: g03001.D8.Was this device serviced by a third party? no.The investigation included review of product historical data and product labeling.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.A review of cell-dyn ruby risk analysis (cd34-sys-104, version 10.4) shows that a hazard, ha561 is related to the incident that was described by the customer.Control measures for ha561 include, instructions in service manual, design of barbed fittings, and instructions in the operator¿s manual to wear personal protective equipment when operating instrument.Based on the investigation, no product deficiency was identified for the complaint issue.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field h10.There is no change to the content of the data.

• Brand Name: CELL-DYN RUBY SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 11252550
• MDR Text Key: 248882037
• Report Number: 2919069-2021-00001
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08H67-01
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1