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 05/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed falsely elevated hemoglobin results generated on the cell dyn ruby analyzer that were 2 times higher than sysmex.On (b)(6) 2022, the cell dyn ruby hemoglobin result for sid (b)(6) was 23.4, the sysmex hemoglobin result was 10.0 no impact to patient management was reported.

Manufacturer Narrative

The investigation included a review of the complaint text, product labeling, and product historical data.After replacing the hgb lyse reagent with cd32/r hgb noc.Their cell-dyn ruby analyzer reported an hgb result of 23.4 while their system analyzer reported an hgb result of 10.0.The issue was resolved with replacement of the hgb lyse reagent again.A photograph of the product label on the reagent cubitainer was submitted for review.Based on the information provided, the complaint issue occurred upon first use of cd32/r hgb noc.The complaint text indicated that the customer only runs background and quality control (qc) in the morning.The customer did not run background or qc after replacement of the reagent and before running patient specimens.Review of the cell-dyn ruby system operator¿s manual (9212934g¿november 2017), found the following statements in section 9, "service and maintenance", in the subsection, "reagent container replacement": "it is recommended to run at least five background counts to rinse the system and verify that the background counts are within acceptable limits before running controls or patient specimens." section 11, "quality control", provides recommendations for, "when to run qc", and states that, "controls should be run.After a reagent lot number change".Labeling was found to be adequate for the complaint issue.Trending review did not identify any trends for the complaint issue.Based on all reviewed data, a product deficiency was not 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: 14655057
• MDR Text Key: 301989445
• Report Number: 2919069-2022-00013
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• 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: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1