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

Model Number 08H67-01

Device Problem High Test Results (2457)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

The customer observed a falsely increased wbc result on one patient on the cell-dyn ruby analyzer which did not match clinical history so the customer repeated and result was lower.The following data was provided: processed on (b)(6) 2023 initial results wbc = 94.4 repeat results = 12 unit = 10e3/ul.No impact to patient management was reported.

Manufacturer Narrative

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

Event Description

The customer observed a falsely increased wbc result on one patient on the cell-dyn ruby analyzer which did not match clinical history so the customer repeated and result was lower.The following data was provided: sid (b)(6) processed on (b)(6) 2023 initial results wbc = 94.4 repeat results = 12 unit = 10e3/ul no impact to patient management was reported.

Manufacturer Narrative

The customer reported falsely elevated wbc (woc) results for one patient sample on the cell-dyn ruby, serial number (s/n) (b)(6).Maintenance, calibration, event and setpoints logs, and current dilution factors were reviewed.Review of the gain settings determined the setpoints for woc 90° are below the nominal gains setting range (1200 ¿ 1700).A review of all complaints associated and a review of complaint trends for the list number was performed.The review did not identify any adverse trends.Additionally, labeling was reviewed and adequately addressed the issue under review.Based on the investigation, no systemic issue or deficiency of the cell-dyn ruby, serial number (s/n) (b)(6) was identified.

• 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: 16552501
• MDR Text Key: 311873064
• Report Number: 2919069-2023-00008
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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: 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1