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 Date 06/29/2019

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete all available patient information was included.Additional patient details are not available.

Event Description

The customer reported a discrepant hemoglobin result generated on the cell-dyn ruby analyzer on one patient.Results provided: (b)(6) 2019 = 17.6 / 7.71 / 7.67 / 7.71 g/dl.There was no impact to patient management reported.

Manufacturer Narrative

The investigation included review of submitted data, product history, labeling, and consultation with abbott medical affairs.Review of the product history did not find a similar issue.Based on the submitted data, involvement of pre-analytical elements, such as inadequate mixing of sample, cannot be eliminated.The cell-dyn ruby system operators manual, provides information related to the operational precautions and limitations of the cd ruby system.No product deficiency 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: 8798159
• MDR Text Key: 151310062
• Report Number: 2919069-2019-00085
• 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: 09/10/2019

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: 07/02/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1