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

Catalog Number 08H67-01

Device Problem High Test Results (2457)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Completed information for section a1 patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.

Event Description

The customer observed falsely elevated wbc and platelet results generated on the cell-dyn ruby analyzer for multiple samples.(b)(6) platelet results: 992 10e3/ul, 235 10e3/ul.(b)(6) wbc results: 58.5 10e3/ul, 9.45 10e3/ul.(b)(6) platelet results: 1174 10e3/ul, 278 10e3/ul, 264 10e3/ul.No impact to patient management was reported.

Event Description

The customer observed falsely elevated wbc and platelet results generated on the cell-dyn ruby analyzer for multiple samples.Sid (b)(6) platelet results: 992 10e3/ul, 235 10e3/ul.Sid (b)(6) wbc results: 58.5 10e3/ul, 9.45 10e3/ul.Sid (b)(6) platelet results: 1174 10e3/ul, 278 10e3/ul, 264 10e3/ul.No impact to patient management was reported.

Manufacturer Narrative

The field service representative inspected the cell-dyn ruby analyzer and changed valve 68 due to malfunction.This is a nominal open valve located between waste chamber 1 and the vent chamber.The purpose of this solenoid valve is to control the movement of liquid and air (vacuum and pressure).The vent chamber allows other chambers (e.G., wbc, rbc, hgb mixing chambers, waste chambers) to equalize to atmospheric pressure for effective function.Waste chamber 1 is also connected to the outlet of the peristaltic pump tubing.It is possible that the malfunction of valve 68, may have affected the sample staging done by the peristaltic pump tubing.If valve 68 was not able to close when prompted by the instrument, it may have caused a pressure disequilibrium on waste chamber 1 that may have impacted the peristaltic pump function.The issue was resolved when the field service representative replaced valve 68.A review of tracking and trending of the cell-dyn ruby did not identify any trends for the complaint issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency for the cell-dyn ruby serial number (b)(6) was identified.All available patient information was included.Additional patient details are not available.

• 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: 17468864
• MDR Text Key: 320579174
• Report Number: 2919069-2023-00022
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOLENOID VALVE ASSY, 3.9 KG WHT (NO WSHR), 8921122