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

Catalog Number 04U42-84

Device Problem High Test Results (2457)

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

Event Date 10/21/2023

Event Type  malfunction  

Event Description

The customer reported that an imprecision issue exists on a cell-dyn ruby analyzer.The customer reported that a sample had an initial wbc result of 13 10e3.This sample was processed again in the afternoon, which generated a result of 40 10e3.The sample was repeated again and generated a result of 12 10e3.There was no reported impact to patient management.

Manufacturer Narrative

This report is being filed on an international product, list number 04u42-84 and there is a similar product distributed in the us, list number 8h67.All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Section d8 was corrected.

Event Description

The customer reported that an imprecision issue exists on a cell-dyn ruby analyzer.The customer reported that a sample had an initial wbc result of 13 10e3.This sample was processed again in the afternoon, which generated a result of 40 10e3.The sample was repeated again and generated a result of 12 10e3.There was no reported impact to patient management.

Manufacturer Narrative

The cell-dyn ruby analyzer, serial number: (b)(6)was inspected, and it was noted that multiple valves and a closed mode needle required replacement.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of ticket tracking and trending did not identify a trend for the cell-dyn ruby, nor was an increase in complaint activity found.A review of the manufacturing documentation did not identify any product issues.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the cell-dyn ruby analyzer, serial number: (b)(6).

Event Description

The customer reported that an imprecision issue exists on a cell-dyn ruby analyzer.The customer reported that a sample had an initial wbc result of 13 10e3.This sample was processed again in the afternoon, which generated a result of 40 10e3.The sample was repeated again and generated a result of 12 10e3.There was no reported impact to patient management.

• 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden N39 E-932 ; GM N39 E932 ; 6122582960
• MDR Report Key: 18186206
• MDR Text Key: 328710403
• Report Number: 2919069-2023-00047
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04U42-84
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1