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

Model Number 08H67-01

Device Problem Smoking (1585)

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

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

An abbott field service engineer observed smoke coming from the cell-dyn ruby analyzer.There was no report of fire or any injury.

Manufacturer Narrative

The cell-dyn ruby instrument was in the daily maintenance status when the smoke was observed.There was no injury as no one was in the lab at that time.No fire was seen only smoke.No damages to the surrounding areas were reported.The electrician was called to check the facility and the instrument was unplugged.It was found that fluid from the instrument¿s waste drain was the source of the problem.There were some changes in the lab and the waste drain was not properly installed by the customer.After the waste drain was properly installed, the issue was resolved.A review of all tickets associated with the cell-dyn ruby and a review for complaint trends for the list number was performed.The review did not identify any adverse trends and the complaint activity was normal.Additionally, labeling was reviewed and adequately addressed the issue.Based on this information, a deficiency was not identified.A malfunction was not identified.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site.Use error caused the issue as the waste drain was not properly installed by the user.

• 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
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14961429
• MDR Text Key: 303098062
• Report Number: 2919069-2022-00019
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: BD
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1