MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN RUBY ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 08H67-01

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer observed a falsely elevated wbc result while using the cell-dyn ruby analyzer.The customer indicated the elevated result was generated in closed mode versus the result in open mode, as follows ((b)(4)): closed: 198 m/ul (198000/ul) open: 9.16 m/ul (9160/ul) , woc counts varied, 198 and 48.9, for this specimen.No impact to patient management was reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the instrument log data, instrument troubleshooting, a search for similar complaints, and a review of labeling.Return parts were not available.Review of the instrument log data indicated that three tests runs were performed and each run generated invalid data flags.The analyzer presented the suspect population flags in all runs, suggesting the need for verification of results by alternative methods.Field service was requested, and field service replaced the closed mode needle and cleaned the hemoglobin flow cell, hemoglobin chamber and optical flow cell to resolve the observation of increased invalidating flags.Based on these results, the cell-dyn was performing as designed.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the cell-dyn ruby analyzer, list number 08h67 was identified.

• Brand Name: CELL-DYN RUBY ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 8527516
• MDR Text Key: 160422999
• Report Number: 2919069-2019-00036
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/18/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 07/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1