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 Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).No further information was provided.

Event Description

The customer obtained a falsely elevated wbc result while using the cell-dyn ruby analyzer.Sample id: (b)(6) generated a wbc result of 66.6 10e3 /ul in closed mode, and repeat of 6.71 10e3/ul in open mode.No impact to patient management was reported.

Event Description

The customer obtained a falsely elevated wbc result while using the cell-dyn ruby analyzer.Sample id (b)(6) generated a wbc result of 66.6 10e3 /ul in closed mode and repeat of 6.71 10e3/ul in open mode.No impact to patient management was reported.

Manufacturer Narrative

Investigation of the complaint issue included review of the incident and information provided by the customer, review of historical product data and labeling.Field service inspected the analyzer and verified performance by processing controls and samples in closed and open mode with no issues identified.Review of complaint and trending data associated with the issue did not identify any trends or abnormal complaint activity.Based on the investigation, no deficiency or systemic issue was identified for the cell-dyn ruby analyzer.

• 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
• MDR Report Key: 10718645
• MDR Text Key: 213209636
• Report Number: 2919069-2020-00034
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• 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
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1