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

Model Number 08H67-01

Device Problem Output Problem (3005)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Patient information: no further information was provided.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported a sample id mismatch while using the cell-dyn ruby analyzer.The customer indicate the issue occurred while running in open mode and provided a video to demonstrate the issue.The customer manually entered sample id (b)(6) and when the results were generated under sample id (b)(6) on the ruby.A second sample was manually entered as (b)(6) and the results were generated under (b)(6) on the ruby.No incorrect results were reported out of the lab.No adverse impact to patient management was reported.

Manufacturer Narrative

The investigation included review of the product historical data, product labeling, complaint text and information provided by the customer.Review of product historical data for any trends and all customer complaints received for this issue did not identify any trends or issues.Review of the incident and video provided by the customer, identified an anomaly occurred possibly related to changes in the time zone or time on the analyzer.Several attempts were made to reproduce the events using an in-house cell-dyn ruby instrument with the same operating system and software version (2.3ml) by changing time zones (pst to cst and cst to pst) and setting the system time backwards or forwards relative to the data log.In all cases neither the time nor patient i.D.Mismatch could be reproduced as described by the customer in this ticket.Based on the investigation, no deficiency or systemic issue was identified for the cell-dyn ruby analyzer.

• 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: 12297716
• MDR Text Key: 266034065
• Report Number: 2919069-2021-00016
• 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
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• 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: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1