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

Model Number 08H67-01

Device Problem Low Test Results (2458)

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

Event Date 08/31/2021

Event Type  malfunction  

Event Description

The account generated a false depressed cell-dyn ruby hemoglobin of 7.55 g/dl on (b)(6) 2021.A second sample processed on (b)(6) 2021 generated cell-dyn ruby hemoglobin of 9.29 g/dl.No specific patient information was provided.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Manufacturer Narrative

The field service engineer (fse) visited the site and checked the cleanliness and voltage of the hgb flow cell.Fse also verified the controls and blood count for hgb and hct and they were within the range.No instrument issues were identified in this visit.The investigation included review of product historical data and product labeling.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.A review of the product labeling concluded that the issue is sufficiently addressed.Additional data was requested from the account but not provided.Due to limited data availability, further investigation could not be performed.Based on the investigation, no product deficiency was identified for cell-dyn ruby.

• 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12817912
• MDR Text Key: 284467766
• Report Number: 2919069-2021-00023
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1