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

Catalog Number 08H67-01

Device Problem High Test Results (2457)

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

The customer observed falsely elevated white blood cell (wbc) results generated from cell dyn ruby analyzer for several patients.The one result example provided which does not match with patient clinical picture.The results were: initial=93 10e3/ul /repeated=90 and 85 10e3/ul.The customer expected to be normal wbc result within normal laboratory reference range for this patient.Laboratory reference range for wbc=5 to 10 10e3/ul there was no reported impact to patient management.

Manufacturer Narrative

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

Manufacturer Narrative

During the requested site visit, the field service engineer (fse) performed troubleshooting procedures and found that accumulated dirt was found in the tubing connected to the flow cell.A review of the tracking and trending report determined that there are no trends for the product for the complaint issue.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 information provided, the issue was resolved by service.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the ruby analyzer, serial number (b)(6).

Event Description

The customer observed falsely elevated white blood cell (wbc) results generated from cell dyn ruby analyzer for several patients.The one result example provided which does not match with patient clinical picture.The results were: initial=93 10e3/ul /repeated=90 and 85 10e3/ul the customer expected to be normal wbc result within normal laboratory reference range for this patient.Laboratory reference range for wbc=5 to 10 10e3/ul 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: 18093776
• MDR Text Key: 327652234
• Report Number: 2919069-2023-00046
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1